Medical device for transcutaneously inserting an insertable element into a body tissue

ABSTRACT

A medical device for transcutaneously inserting an insertable element into a body tissue. The medical device includes an insertable element that has an in vivo distal end for subcutaneous insertion, an ex vivo proximal end, and a pre-bended insertion cannula for subcutaneously inserting the insertable element. The medical device further comprises at least one patch, which is configured to be mounted on the skin of a user. The patch has a patch base and an integrated insertion mechanism for driving the insertion cannula from a storage position within the patch into an inserted position within the body tissue on a curved insertion path.

RELATED APPLICATIONS

This application is a continuation of PCT/EP2017/065290, filed Jun. 21,2017, which claims priority to EP 16 194 823.7, filed Oct. 20, 2016, andEP 16 175 696.0, filed Jun. 22, 2016, the entire disclosures of thethree of which are hereby incorporated herein by reference.

BACKGROUND

This disclosure relates to a medical device for transcutaneouslyinserting an insertable element into a body tissue, an analytemeasurement device for detecting at least one analyte in a body fluid, amedication device for delivering at least one medication to a user and amethod for transcutaneously inserting an insertable element into a bodytissue. The devices and method according to the present disclosure maymainly be used for long-term monitoring of an analyte concentration in abody fluid, such as for long-term monitoring of a blood glucose level orof the concentration of one or more other types of analytes in a bodyfluid. The invention may both be applied in the field of home care aswell as in the field of professional care, such as in hospitals. Otherapplications are feasible.

Monitoring certain body functions, more particularly monitoring one ormore concentrations of certain analytes, plays an important role in theprevention and treatment of various diseases. Without restrictingfurther possible applications, the invention will be described in thefollowing text with reference to blood-glucose monitoring. However,additionally or alternatively, the invention can also be applied toother types of analytes.

Blood glucose monitoring, besides by using optical measurements,specifically may be performed by using electrochemical biosensors.Examples of electrochemical biosensors for measuring glucose,specifically in blood or other body fluids, are known from U.S. Pat.Nos. 5,413,690 A, 5,762,770 A, 5,798,031 A, 6,129,823 A or US2005/0013731 A1.

In addition to so-called spot measurements, in which a sample of abodily fluid is taken from a user in a targeted fashion and examinedwith respect to the analyte concentration, continuous measurements areincreasingly becoming established. Thus, in the recent past, continuousmeasuring of glucose in the interstitial tissue (also referred to ascontinuous monitoring, CM) for example has been established as anotherimportant method for managing, monitoring and controlling a diabetesstate.

In the process, the active sensor region is applied directly to themeasurement site, which is generally arranged in the interstitialtissue, and, for example, converts glucose into electrical charge byusing an enzyme (e.g. glucose oxidase, GOD), which charge is related tothe glucose concentration and can be used as a measurement variable.Examples of such transcutaneous measurement systems are described inU.S. Pat. No. 6,360,888 B1 or in US 2008/0242962 A1.

Hence, current continuous monitoring systems typically aretranscutaneous systems or subcutaneous systems, and both expressions, inthe following, will be used equivalently. This means that the actualsensor, or at least a measuring portion of the sensor, is arranged underthe skin of the user. However, an evaluation and control part of thesystem (also referred to as a patch) is generally situated outside ofthe body of the user, outside of the human or animal body. In theprocess, the sensor is generally applied using an insertion instrument,which is likewise described in U.S. Pat. No. 6,360,888 B1 in anexemplary fashion. Other types of insertion instruments are also known.

The sensor typically comprises a substrate, such as a flat substrate,onto which an electrically conductive pattern of electrodes, conductivetraces and contact pads may be applied. In use, the conductive tracestypically are isolated by using one or more electrically insulatingmaterials. The electrically insulating material typically also acts as aprotection against humidity and other detrimental substances and, as anexample, may comprise one or more cover layers such as resists.

As outlined above, in transcutaneous systems, a control part istypically required, which may be located outside the body tissue andwhich has to be in communication with the sensor. Typically, thiscommunication is established by providing at least one electricalcontact between the sensor and the control part, which may be apermanent electrical contact or a releasable electrical contact.Examples of electrical contacts for contacting a triangular assembly ofcontact pads are shown e.g. in DE 954712 B. Other techniques forproviding electrical contacts, such as by appropriate spring contacts,are generally known and may be applied.

In order to avoid detrimental effects of the aggressive environment ontothe conductive properties of the electrical contact, the region of theelectrical contact is typically encapsulated and protected againsthumidity. Generally, encapsulations of electrical locks and contacts byusing appropriate seals is known from, e.g., DE 200 20 566 U1.Specifically in transcutaneous or subcutaneous sensors, in which theregion of electrical contact between the sensor and the control part isclose to the human skin, an efficient protection against humidity, dirt,sweat and detergents, such as detergents used for body care, is crucial.

U.S. Pat. No. 8,954,162 B2 discloses a method for implanting a medicaldevice proximate to a target tissue site within an occipital region of apatient, such as proximate to an occipital nerve or a trigeminal nerve.The method comprises introducing an implant tool into a patient todefine an insertion path to the target tissue site. The implant toolincludes a shape memory cannula and a malleable needle at leastpartially disposed within an inner lumen of the cannula. The shape ofthe needle may be changed to accommodate different anatomicalstructures/features of the patient. Upon withdrawal of the needle fromthe cannula, the cannula may change shape, thereby changing the shape ofthe insertion path.

WO 2011/041463 A2 discloses a transcutaneous sensor device configuredfor continuously measuring analyte concentrations in a host. In someembodiments, the transcutaneous sensor device comprises an in vivoportion configured for insertion under the skin of the host and an exvivo portion configured to remain above the surface of the skin of thehost after sensor insertion of the in vivo portion. The in vivo portionmay comprise a tissue piercing element configured for piercing the skinof the host and a sensor body comprising a material or support memberthat provides sufficient column strength to allow the sensor body to bepushed into a host tissue without substantial buckling. The ex vivoportion may be configured to comprise (or operably connect to) a sensorelectronics unit and may comprise a mounting unit. Also described hereare various configurations of the sensor body and the tissue piercingelement that may be used to protect the membrane of the sensor body.

US 2012/0253145 A1 discloses systems and methods for transcutaneouslyimplanting medical devices, such as in vivo analyte sensors. The systemsand methods involve the use of introducers or inserters made of shapememory alloy (SMA) materials which are able to transition from oneoperative state or configuration to another operative state orconfiguration, wherein the transition from state to state enables thetranscutaneous implantation and/or transcutaneous explantation of themedical device.

Despite the advantages and the progress achieved by the above-mentioneddevelopments, specifically in the field of continuous monitoringtechnology, some significant technical challenges remain. An assembly ofa plurality of components is generally required, which typically impliesa complex and costly manufacturing process. Further, known techniquesgenerally require voluminous components, which is an issue, specificallyconsidering the fact that miniaturizing the sensor systems is a factorcontributing to the convenience of use.

SUMMARY

The present disclosure provides a medical device for transcutaneouslyinserting an insertable element into a body tissue, an analytemeasurement device for detecting at least one analyte in a body fluid, amedication device for delivering at least one medication to a user and amethod for transcutaneously inserting an insertable element into a bodytissue, which at least partially avoid the shortcomings of known devicesand methods of this kind and which at least partially address theabove-mentioned challenges. Specifically, devices and methods shall bedisclosed which allow for easy manufacturing and simple handlingprocesses by a user.

Disclosed herein is a medical device for transcutaneously inserting aninsertable element into a body tissue, an analyte measurement device fordetecting at least one analyte in a body fluid, a medication device fordelivering at least one medication to a user and a method fortranscutaneously inserting an insertable element into a body tissue. Themedical device may also include other features disclosed herein, eithersingly or in various combinations of such features.

As used in the following, the terms “have”, “comprise” or “include” orany arbitrary grammatical variations thereof are used in a non-exclusiveway. Thus, these terms may refer to a situation in which, besides thefeature introduced by these terms, no further features are present inthe entity described in this context and to a situation in which one ormore further features are present. As an example, the expressions “A hasB”, “A comprises B” and “A includes B” may refer to a situation inwhich, besides B, no other element is present in A (i.e. a situation inwhich A solely and exclusively consists of B) and to a situation inwhich, besides B, one or more further elements are present in entity A,such as element C, elements C and D or even further elements.

Further, it shall be noted that the terms, when used herein, “at leastone,” “one or more” or similar expressions indicating that a feature orelement may be present once or more than once typically will be usedonly once when introducing the respective feature or element. In thefollowing, in most cases, when referring to the respective feature orelement, the expressions “at least one” or “one or more” will not berepeated, notwithstanding the fact that the respective feature orelement may be present once or more than once. In the same connection,regardless of whether the phrases “one or more” or “at least one”precede an element or feature presented in this disclosure or claims, itshall be understood that such element or features shall not receive asingular interpretation unless it is made explicit herein. By way ofnon-limiting example, in the absence of any explicit language to thecontrary, the terms “analyte,” “insertable element,” “in vivo distalend,” and “ex vivo proximal end” to name just a few, should beinterpreted to mean “at least one” or “one or more” regardless ofwhether or not they are introduced with the expressions “at least one”or “one or more.” All other terms used herein should be similarlyinterpreted unless it is made explicit that a singular interpretation isintended.

Further, as used in the following, the terms “preferably”, “morepreferably”, “particularly”, “more particularly”, “specifically”, “morespecifically” or similar terms are used in conjunction with optionalfeatures, without restricting alternative possibilities. Thus, featuresintroduced by these terms are optional features and are not intended torestrict the scope of the claims in any way. The disclosure may, as theskilled person will recognize, be performed by using alternativefeatures. Similarly, features introduced by “in an embodiment” orsimilar expressions are intended to be optional features, without anyrestriction regarding alternative embodiments of the invention, withoutany restrictions regarding the scope of the invention and without anyrestriction regarding the possibility of combining the featuresintroduced in such way with other optional or non-optional features.

In a first embodiment, a medical device for transcutaneously insertingan insertable element into a body tissue is disclosed. The medicaldevice comprises at least one insertable element. The insertable elementcomprises at least one in vivo distal end for subcutaneous insertion andat least one ex vivo proximal end. Further, the medical device comprisesat least one insertion cannula for subcutaneously inserting theinsertable element. The insertion cannula has a lumen which is fully orpartially enclosed by a wall of the insertion cannula. The insertableelement is received in the lumen. The insertion cannula is a pre-bendedinsertion cannula. The medical device further comprises at least onepatch, configured to be mounted onto the skin of a user. The patchcomprises a patch base. The patch comprises an integrated insertionmechanism for driving the insertion cannula from a storage positionwithin the patch into an inserted position within the body tissue on acurved insertion path.

As generally used within the present disclosure, the term “medicaldevice” may refer to an arbitrary device configured for conducting atleast one medical analysis and/or at least one medical procedure. Themedical device therefore generally may be an arbitrary device configuredfor performing at least one diagnostic purpose and/or at least onetherapeutic purpose. In the following, without restricting furtherembodiments, the medical device mainly will be described in terms of amedical device configured for performing at least one diagnostic purposeand, specifically, a medical device comprising at least one analytesensor for performing at least one analysis. The medical devicespecifically may comprise an assembly of two or more components capableof interacting with each other, such as in order to perform one or morediagnostic and/or therapeutic purposes, such as in order to perform themedical analysis and/or the medical procedure. Specifically, the two ormore components may be capable of performing at least one detection ofthe at least one analyte in the body fluid and/or contribute to the atleast one detection of the at least one analyte in the body fluid. Themedical device generally may also be or may comprise at least one of asensor assembly, a sensor system, a sensor kit or a sensor device.

The medical device generally may be used for detecting at least oneanalyte in a body fluid of a user. Specifically, the medical device maybe used for long-term monitoring or continuous monitoring of an analyteconcentration in the body fluid of the user, such as in a body fluidcontained in a body tissue of the user.

As generally used within the present disclosure, the terms “patient” and“user” may refer to a human being or an animal, independent of the factthat the human being or animal, respectively, may be in a healthycondition or may suffer from one or more diseases. As an example, thepatient or the user may be a human being or an animal suffering fromdiabetes. However, additionally or alternatively, the disclosure may beapplied to other types of users or patients or diseases.

The term “body tissue” may generally refer to a cellular organizationallevel intermediate between cells and a complete origin. The body tissuemay specifically be an ensemble of similar cells from the same originthat together carry out a specific function. Thereby, organs may then beformed by functional grouping together of multiple tissues. For example,interstitial tissue, i.e. connective tissue between cellular elements ofa structure, may be called “body tissue.” As further used herein, theterm “body fluid” generally may refer to a fluid which is typicallypresent in a body or the body tissue of the user or the patient and/orwhich may be produced by the body of the user or the patient. Thus, asan example, the body fluid may be selected from the group consisting ofblood and interstitial fluid. However, additionally or alternatively,one or more other types of body fluids may be used, such as saliva, tearfluid, urine or other body fluids.

The term “transcutaneous” generally refers to a property of an arbitraryelement of being adapted to be fully or at least partly extendingthrough the body tissue of the patient or the user. For this purpose,the element may comprise an insertable portion. In order to furtherrender the element to be usable as a transcutaneous element, the elementmay fully or partially provide a biocompatible surface, i.e. a surfacewhich, at least during durations of use, does not have any detrimentaleffects on the user, the patient or the body tissue. Further, thetranscutaneous element generally may be dimensioned such that atranscutaneous insertion of the element into the body tissue isfeasible, such as by providing a width in a direction perpendicular toan insertion direction of no more than 5 mm, preferably of no more than2 mm, more preferably of no more than 1.5 mm. Thus, the term“subcutaneous” may generally refer to a property of an arbitrary elementof being situated or lying under the skin and within the body tissue ofthe user or the patient. Specifically, the object may be configured tobe introduced under the skin, exemplarily as an injection.

As further used herein, the term “insertion cannula” may refer to anarbitrary element which may be insertable at least partially into anarbitrary body tissue, particularly in order to deliver or to transfer afurther element. Therefore, the insertion cannula may specifically be ormay comprise a hollow tube or a hollow needle.

As described above, the insertion cannula has a lumen which is fully orpartially enclosed by a wall of the insertion cannula. The term “lumen”generally refers to an interior volume of an element. The interiorvolume may specifically be an open interior volume. Thus, the interiorvolume may not be fully enclosed or surrounded by a wall of the element.Instead, a flow of a fluid medium or an insertion of another object fromone end of the element to a further end through the lumen may befeasible. As further used herein, the term “wall” may generally refer toan arbitrary structure, specifically a structural material, which isconfigured to at least partially surround another object or volumethereby defining physical limits of an object. Further, the wall may beconfigured to protect the volume or the other object at least partiallyenclosed by the wall.

Specifically, the insertion cannula may be selected from the groupconsisting of: a closed cannula with the wall circumferentiallyenclosing the lumen; a slotted cannula, with the cannula having a slotextending in an axial direction. The term “circumferentially enclosing”may generally refer to a property of an arbitrary object or volume ofbeing fully enclosed by another object in at least two dimensions.Specifically, the lumen of the insertion cannula may be fully enclosedby the insertion cannula in directions perpendicular to a direction ofextension of the insertion cannula. The term “slot” may generally referto an opening, a slit or to a notch configured for receiving oradmitting something. Specifically, the slotted cannula may comprise aslot located at one end of the insertion cannula. Thereby, the slot mayform an angle of 10° to 80°, more preferably of 20° to 60°, to alongitudinal axis of the insertion cannula. The slot may be configuredto facilitate an insertion of the insertion cannula into the bodytissue. Optionally, the insertion cannula may comprise a further slot.The further slot may have an elongate shape and may extend along thelongitudinal axis of the insertion cannula.

The insertion cannula at least partially may have an essentiallyrectangular shape. The term “shape” may thereby refer to a cross-sectionperpendicular to a direction of extension of the insertion cannula orperpendicular to the longitudinal axis of the insertion cannula. Theterm “essentially rectangular” may refer to a property of the shape ofhaving slight deviations of a rectangular shape such as by smalldeviations of an angle of 90° between the walls of the insertioncannula. The advantage of the essentially rectangular shape of theinsertion cannula is that a geometric relation between the insertioncannula and the insertable element, which may specifically be anessentially rectangular insertable element, as will further be describedbelow, may be optimized. Further, the insertion cannula having theessentially rectangular shape may show the advantage that the insertioncannula may be flexible in a vertical axis and may be stiff in atransverse axis of the insertion cannula. Further, a force which isrequired to insert the insertable element may be reduced with theessentially rectangular shape in comparison to a usage of insertioncannulas with other shapes. Further, an injury of the patient may bereduced. Further, the insertion cannula may at least partially have anasymmetric shape. Thus, the cross-section perpendicular to the directionof extension of the insertion cannula may be non-symmetric with regardto an axis perpendicular to the direction of extension. However, othershapes of the insertion cannula may generally be feasible.

The insertion cannula may at least partially be made of at least onebiocompatible material, i.e. a surface which, at least during durationsof use, does not have any detrimental effects on the user, the patientor the body tissue. As an example, the insertion cannula, specificallythe in vivo distal end, may fully or partially be covered with at leastone biocompatible membrane, such as at least one polymer membrane or gelmembrane which is permeable for the analyte and/or the body fluid.

As outlined above, the insertion cannula is a pre-bended insertioncannula. As used herein, the term “pre-bended” may generally refer to ageometric property of an element which, at least in absence of externalforces, is an at least partially non-straight shape. Thus, the insertioncannula, at least in absence of external forces, may be at leastpartially non-straight. Thus, the insertion cannula may fully orpartially be embodied as having a non-straight shape, specifically asfully or partially having a curved shape. Specifically, the insertioncannula may fully or partially be embodied as having the shape of asegment of a circle. Thus, the insertion cannula may be pre-bended insuch a way that it fully or partially has the shape of a segment of acircle. More specifically, as an example, the pre-bended insertioncannula may be a steel cannula, specifically a stainless steel cannula,being pre-bended in such a way that it fully or partially is curved,specifically having the shape of a segment of a circle. The insertioncannula may be a stiff or rigid insertion cannula. Alternatively,however, the insertion cannula may also be flexible, specifically withrespect to a change of a bending radius of the pre-bended insertioncannula. The insertion cannula, as an example, may also be made ofmaterials that do not include a shape memory alloy.

As outlined above, the integrated insertion mechanism is configured fordriving the insertion cannula from a storage position within the patchinto an inserted position in which the insertion cannula is fully orpartially extended into the body tissue. As used herein, the term“storage position” generally may refer to a position of the insertioncannula within the patch, in which the insertion cannula does notprotrude into the body tissue. Specifically, the insertion cannula mayfully or partially be surrounded by the patch. As further used herein,the term “inserted position” may generally refer to a position of theinsertion cannula in which the insertion cannula fully or partiallyprotrudes from the patch, such as by fully or partially protruding intothe body tissue while preferably a proximal end of the insertion cannulais fully or partially held by the patch or connected to the patch.

In the storage position and in the inserted position, the insertioncannula may have the same shape or may have a different shape. Thus, asan example, the insertion cannula, when inside the patch, may have aflattened shape with a higher bending radius as compared to a situationin which the insertion cannula is fully or partially outside the patch.Alternatively, however, the insertion cannula may also have the samebending radius or the same shape in the storage position, i.e. in thefirst configuration, and in the inserted position, i.e. in the secondconfiguration. In the latter case, as an example, the cannula may be aflexible cannula, which is pre-bended in such a way that, in the absenceof external forces, it takes the second configuration.

The situation of the insertion cannula in which the insertion cannula isin the storage position may also be referred to as a first configurationof the insertion cannula or the medical device, and the situation inwhich the insertion cannula is in the inserted position may also bereferred to as a second configuration. The terms “first configuration”and “second configuration” may be considered as nomenclature only,without numbering or ranking the named elements, without specifying anorder and without excluding a possibility that several kinds of firstconfigurations and second configuration may be present. Further,additional configurations such as one or more third configurations maybe present.

The insertion cannula may comprise at least one relief cutout in thewall of the insertion cannula. The term “relief cutout” specifically mayrefer to a passage opening within the wall of the insertion cannula. Therelief cutout may be configured to support a transformation of theinsertion cannula from the first configuration to the secondconfiguration. The relief cutout may extend essentially perpendicular toan axis of the insertion cannula.

The term “insertable element” may generally refer to an arbitraryelement which may be configured to be at least partially insertable intoanother object such that the insertable element may be at leastpartially located under the object or surrounded by an interior of theobject. Specifically, the insertable element may be configured to be atleast partially inserted into the body tissue, specifically under theskin of the patient. Therefore, the insertable element may specificallyhave an elongate shape with a small cross-section.

Further, the insertable element may be configured to be removed from thebody tissue subsequent to an expiration of a useful lifetime of themedical device. The term “useful lifetime” may refer to a period of timeduring which an arbitrary device may be applied in an intended manner.Specifically, the medical device may be configured to stay mounted ontothe skin of the patient or the user for several days such as for oneweek or for two weeks. During this period of time, the medical devicemay be configured to conduct analytical measurements and/or to transferan infusion into the body tissue, as will further be described below.Further, during this period of time, the insertable element may staywithin the body tissue and the insertion cannula may also stay withinthe body tissue subsequent to the insertable element. Alternatively, theinsertion cannula may be configured to be fully withdrawn from the bodytissue into the medical device after insertion of the insertable elementwhile only the insertable element is configured to stay at leastpartially within the body tissue after the insertion cannula iswithdrawn into the medical device and during the useful lifetime of themedical device. Meanwhile, the insertion cannula may stay outside of thebody tissue but may be incorporated within the medical device.Specifically, the insertion cannula may be protectively enclosed by themedical device such that the insertion cannula may not be a source ofrisk to the user or the patient. Thus, the user or the patient may havethe insertion cannula protectively enclosed by the medical device,specifically by a housing of the medical device attached to the bodytissue via the medical device. Thus, the insertion cannula and theinsertable element may be configured to be removed from the body of thepatient at the same time after the useful time of the medical device isexpired.

As described above, the insertable element may comprise the in vivodistal end and, optionally, the ex vivo proximal end. As further usedherein, the term “in vivo distal end” may refer to a part, specificallyto an end of an object which is configured to be at least partiallyinsertable into a living organism, specifically into a body tissue.Therefore, the in vivo distal end may refer to an end opposing an endwhich corresponds to a point of attachment of the object. The term “exvivo proximal end” may refer to a part, specifically to an end of anobject which is configured to stay outside of a living organism.Therefore, the ex vivo proximal end may refer to an end whichcorresponds to a point of attachment of the object. Thus, the in vivodistal end and the ex vivo proximal end may be opposing ends of onesingle object, whereby the object is configured to be partially insertedinto a living organism via the in vivo distal end while one part of theobject may stay outside of the living organism. Generally, theinsertable element may have an elongate shape with a smallcross-section. The insertable element may be at least partially made ofa biocompatible material. Further, the insertable element may, at leastto a large extent, be made of an elastic material.

The insertable element may be selected from the group consisting of: asensor, specifically a biosensor, preferably an analyte sensor fordetecting at least one analyte in a body fluid; a sensor configured forremaining under the skin after removing the insertion cannula; aninfusion cannula; a dosing tube.

As further used herein, the terms “sensor” and “analyte sensor” maygenerally refer to an arbitrary element which is adapted to perform aprocess of detection and/or which is adapted to be used in the processof detection. Thus, the sensor specifically may be adapted to determinethe concentration of the analyte and/or a presence of the analyte. Theterm “detection” generally refers to a process of determining a presenceand/or a quantity and/or a concentration of the at least one analyte.Thus, the detection may be or may comprise a qualitative detection,simply determining the presence or the absence of the at least oneanalyte, and/or may be or may comprise a quantitative detection, whichdetermines the quantity and/or the concentration of the at least oneanalyte. As a result of the detection, at least one signal may beproduced which characterizes an outcome of the detection, such as atleast one measurement signal. The at least one signal specifically maybe or may comprise at least one electronic signal such as at least onevoltage and/or at least one current. The at least one signal may be ormay comprise at least one analog signal and/or may be or may comprise atleast one digital signal.

The analyte sensor specifically may be an electrochemical sensor. Asused herein, an “electrochemical sensor” generally is a sensor which isconfigured to conduct an electrochemical measurement in order to detectthe at least one analyte contained in the body fluid. The term“electrochemical measurement” refers to a detection of anelectrochemically detectable property of the analyte, such as anelectrochemical detection reaction. Thus, for example, theelectrochemical detection reaction may be detected by comparing one ormore electrode potentials. The electrochemical sensor specifically maybe adapted to and/or may be usable to generate at least one electricalsensor signal which directly or indirectly indicates the presence and/orthe extent of the electrochemical detection reaction, such as at leastone current and/or at least one voltage. The detection may beanalyte-specific. The measurement may be a qualitative and/or aquantitative measurement. Still, other embodiments are feasible. Theanalyte sensor may comprise at least two electrodes. The two electrodesmay comprise at least one working electrode. As used herein, the term“working electrode” refers to an electrode being adapted for or beingusable for performing at least one electrochemical detection reactionfor detecting the at least one analyte in the body fluid. The workingelectrode may have at least one test chemical being sensitive to theanalyte to be detected. The term “test chemical” specifically may referto an arbitrary material or a composition of materials adapted to changeat least one detectable property in the presence of at least oneanalyte. This property may be an electrochemically detectable property.Specifically, the at least one test chemical may be a highly selectivetest chemical, which only changes the property if the analyte is presentin the body fluid, whereas no change occurs if the analyte is notpresent. The degree of change of the at least one property is dependenton the concentration of the analyte in the body fluid in order to allowa quantitative detection of the analyte. As an example, the testchemical may comprise at least one enzyme, such as glucose oxidaseand/or glucose dehydrogenase. The at least two electrodes may furthercomprise at least one counter electrode. As used herein, the term“counter electrode” refers to an electrode adapted for performing atleast one electrochemical counter reaction and adapted for balancing acurrent flow required by the detection reaction at the workingelectrode. Additionally or alternatively the at least two electrodes mayfurther comprise at least one reference electrode. The referenceelectrode may have a stable and well-known electrode potential. Forpotential materials usable for the counter electrode and/or thereference electrode, reference may be made to WO 2007/071562 A1 and theprior art documents disclosed therein, all of which are herebyincorporated by reference. Other embodiments, however, are feasible.

As further used herein, the term “analyte” may refer to an arbitraryelement, component or compound which may be present in the body fluidand the presence and/or the concentration of which may be of interestfor the user, the patient or medical staff, such as a medical doctor.Particularly, the analyte may be or may comprise an arbitrary chemicalsubstance or chemical compound which may take part in the metabolism ofthe user or the patient, such as at least one metabolite. As an example,the at least one analyte may be selected from the group consisting ofglucose, cholesterol, triglycerides, lactate. Additionally oralternatively, however, other types of analytes may be used and/or anycombination of analytes may be determined. The detection of the at leastone analyte may be an analyte-specific detection.

The analyte sensor may further comprise at least one substrate. The atleast two electrodes and/or at least two sensor contacts generally maybe attached to the substrate. The sensor may further comprise at leasttwo electrical traces which interconnect the electrodes and the sensorcontacts and which may also be attached to the substrate. As usedherein, the term “substrate” may generally refer to an arbitrary elementwhich is suitable to carry one or more other elements disposed thereonor therein. As an example, the substrate may be a flat substrate, suchas a substrate having a lateral extension exceeding its thickness by atleast a factor of 2, at least a factor of 5, at least a factor of 10, oreven at least a factor of 20 or more. The substrate specifically mayhave an elongated shape, such as a strip-shape and/or a bar-shape. Thesubstrate, as an example, may comprise a shaft, specifically a shafthaving an elongate shape. For example, the shaft may have a shapeselected from the group consisting of a strip, a needle, a tape.

The analyte sensor may have a length of less than 50 mm, such as alength of 30 mm or less, e.g. a length of 5 mm to 30 mm. The term“length” as further used herein may be viewed in a direction parallel tothe insertion direction. It shall be noted, however, that otherdimensions are feasible. The analyte sensor may have a shapecorresponding to the shape of the insertion cannula. Specifically, theinsertable element may have a rectangular shape and the analyte sensormay have a rectangular shape correspondingly.

The term “infusion cannula” may generally refer to an arbitrary cannulabeing configured to introduce an infusion, i.e. a liquid substance,specifically a liquid substance comprising a medicine, into the bodytissue, for example, directly into a vein of the patient. Therefore, theinfusion cannula may be attached to a reservoir comprising the liquidsubstance, specifically via the ex vivo proximal end of the infusioncannula. The infusion cannula may be part of an infusion kit. The term“infusion kit” may refer to an assembly of components which are requiredfor conducting an arbitrary infusion. Thus, besides the infusioncannula, the infusion kit may further comprise at least one fluidcoupling for coupling the infusion kit to at least one medicationdevice, preferably to at least one medication pump.

The insertion cannula specifically may fully or partially be made of atleast one material selected from the group consisting of: steel,specifically stainless steel; a plastic material, specifically aflexible plastic material. Specifically, the insertion cannula and thewall may not comprise a shape memory alloy. Thus, specifically, theinsertion cannula may fully or partially be made of one or morematerials other than a shape memory alloy. Thus, as an example, theinsertion cannula may be realized as a bent steel cannula, specificallyas a pre-bended steel cannula, more specifically as a pre-bendedstainless steel cannula. As discussed above, both the firstconfiguration and the second configurations may be pre-bendedconfigurations, specifically bent configurations following an arc of acircle or having an arc form.

As outlined above, the medical device comprises the at least one patch,configured to be mounted onto the skin of a user, wherein the patchcomprises a patch base and an integrated insertion mechanism for drivingthe insertion cannula from a storage position within the patch into aninserted position within the body tissue on a curved insertion path.

As outlined above, during insertion, the insertion cannula may maintainits shape or may be deformed, e.g. relaxed. As an example, the insertioncannula may be forced into the first configuration within the patch andmay relax when being transformed into the second configuration. Thus, asan example, the relaxed form of the insertion cannula may be the secondshape configuration which, specifically, may be bent. Thus, as anexample, the medical device may have a patch or patch base configuredfor attachment to the skin of the user. Before and, optionally, alsoafter insertion, the insertion cannula may be stored within the patch orpatch base, in the storage position or first configuration. Duringinsertion, a tip of the insertion cannula may be pushed out of themedical device, e.g. out of a patch or patch base of the medical device,e.g. through an insertion opening in a bottom surface of the patch orpatch base. When fully extended from the patch or patch base, as anexample, the insertion cannula may take the second configuration. Theinsertion cannula may be bent into a direction facing into the bodytissue. A center of curvature of the insertion cannula may be locatedunderneath the patch or patch base, e.g. in the body tissue. A proximalend of the insertion cannula may be held by the patch or patch base.After insertion, the insertion cannula may be retracted into the patchor patch base by the integrated insertion mechanism, e.g. by beingpulled back into the interior space and/or into the channel of the patchor patch base.

As discussed above, the lumen specifically may have a rectangularcross-section. The insertion cannula specifically may be a slottedinsertion cannula, with a slot located at a short side of therectangular cross-section. Thus, as an example, the insertion cannulamay be a bent, slotted stainless steel cannula having a rectangularcross section, with the longer sides of the rectangle being located atcircumferential surfaces and with the shorter sides being orientedperpendicular thereto, one of the shorter sides having the slot of theinsertion cannula.

As discussed above, the medical device comprises at least one patch,configured to be mounted onto the skin of a user. As used herein, theterm “patch” generally refers to a device which is attachable to theskin or a skin site of a user or a patient. Thus, the patch may compriseat least one attachment component which is capable of connecting thebody mount to the skin, such as at least one adhesive surface and/or atleast one adhesive strip or plaster.

The patch comprises a patch base. As further used herein, the term“base” may refer to an arbitrary support for an object on which furthercomponents of the object rest. Thereby, the base may have a supportingsurface serving bearing area for the further components. Specifically,the patch base may be a flat element. The patch base may comprise abottom surface facing the body tissue of the user or the patient. Thebottom surface may be the adhesive surface as described above. Further,the patch base may comprise an upper surface. The upper surface may beconfigured as bearing surface and may be configured to serve as a hostfor further components of the medical device. Therefore, the patch mayalso be referred to as a sensor support or as a body mount.

The patch comprises the integrated insertion mechanism configured fordriving the insertion cannula from the storage position within the patchinto the inserted position within the body tissue on a curved insertionpath, and, optionally, also for subsequently driving the insertioncannula back from the inserted position into the storage position.

The term “on a curved path”, as used herein, specifically may refer tothe fact that a tip of the insertion cannula, during movement from thestorage position into the inserted position follows a path which, atleast partially, is non-straight. Specifically, the path may at leastpartially have the shape of a segment of a circle.

The term “insertion mechanism” may generally refer to an assembly ofcomponents which are configured to interact with each other with thepurpose of inserting an element at least partially into another object.Therefore, the insertion mechanism may be configured such that amovement of the element in a direction of insertion, i.e. toward asurface of the other object is introduced. The insertion mechanism maybe an integrated insertion mechanism. Thus, the assembly of thecomponents which are configured to interact with each other with thepurpose of inserting the element at least partially into another objectmay be provided as one unit, as a whole and/or as an “all-in-one”system. Thus, the user may find the medical device comprising a fullyassembled insertion mechanism without the need to add other componentsto the medical device or the need to apply a further device in additionto the medical device for the purpose of inserting the insertion cannulainto the body tissue.

The insertion cannula may be at least partially connected to the patchbase and/or placed inside the patch base. Specifically, the insertioncannula may be stored in the first configuration inside the patch. Theinsertion cannula, in the second configuration, may be at leastpartially located outside of the patch or protrude from the patch. Theinsertion cannula may be movable from the patch into the body tissuethrough the passage opening and vice versa. A shape of the passageopening may correspond to a shape of the insertion cannula.Specifically, the shape of the passage opening may correspond to arectangular shape of the insertion cannula.

The insertion mechanism may comprise at least one drive unit. The term“drive unit” may generally refer to an element or an assembly ofelements which are configured to interact with each other in order tocreate a force leading to a movement, specifically a pre-determinedmovement, of another element. Specifically, the drive unit may beconfigured to urge the insertion cannula in a direction of insertion,preferably by pushing or pulling the insertion cannula. The drive unitmay be triggered or driven via a rotational mechanism. The term“rotational mechanism” may refer to a rotational movement of one or morecomponents of an assembly of elements with the purpose to move anotherelement. Thereby, the movement of the material itself may exemplarily bea unidirectional movement.

The medical device may further comprise at least one element connectedor connectable to the patch base, preferably at least one elementinteracting with the insertable element, preferably one of anelectronics unit or a medication pump, particularly via a force-fitconnection.

The integrated insertion mechanism specifically may be or may compriseat least one linear sliding mechanism. The at least one elementconnected or connectable to the patch base specifically may comprise atleast one linear sliding receptacle, and the patch specifically maycomprise at least one linear sliding guide rail, or vice versa. Thelinear sliding receptacle and the linear sliding guide rail, inconjunction, may form a linear sliding connector configured forestablishing a releasable mechanical connection between the at least oneelement connected or connectable to the patch base and the patch.

In case the at least one element connected or connectable to the patchbase comprises at least one electronics unit or another type of elementsuch as a medication pump, the element, specifically the electronicsunit, may comprise at least one bayonet screw. Specifically, theelectronics unit may comprise at least one electronics unit bayonetscrew. The patch may comprise at least one patch bayonet contour,wherein the patch bayonet contour and the electronics unit bayonetscrew, in conjunction, may form a bayonet connector configured forestablishing a releasable mechanical connection between the electronicsunit and the patch.

The at least one element connected or connectable to the patch base, asindicated above, specifically may comprise at least one element selectedfrom the group consisting of: an electronics unit configured forinteracting with the insertable element; a slider, specifically aU-shaped slider; a bracket, specifically a U-shaped bracket.

The at least one element connected or connectable to the patch basespecifically may be configured to be brought from at least one standbyposition into at least one actuated position. As used therein, the term“standby position” generally refers to a position in which the elementconnected or connectable to the patch base is ready to be actuated by auser, e.g. directly or after removal of a securing or safety element.Further, as used therein, the term “actuated position” generally mayrefer to a position in which the element connected or connectable to thepatch base is fully connected to the patch base, e.g., by having reachedan end position in which the element is secured to the patch base. Inthis actuated position, the element connected or connectable to thepatch base may have triggered an insertion of the insertable elementwith the insertion cannula into the body tissue. Further, in thisactuated position, after having inserted the insertable element into thebody tissue, the insertion cannula may already have retracted into thepatch or patch base. For bringing the at least one element connected orconnectable to the patch base from the standby position into theactuated position, specifically, a pushing motion may be used. Thus, thepatch or patch base and the element connected or connectable to thepatch base may be configured for allowing for a pushing motion of theelement, e.g. by providing an appropriate slide or sliding mechanism.

The medical device specifically may be configured for inserting theinsertion cannula into the body tissue, i.e. for bringing the insertioncannula from the storage position or first configuration into theinserted position or second configuration, when the at least one elementconnected or connectable to the patch base is brought into the actuatedposition, such as during the motion from the standby position into theactuated position or when the actuated position has been reached.Additionally, the medical device may further be configured forretracting the insertion cannula, e.g., into the patch or patch base,thereby bringing the insertion cannula back from the inserted positionor second configuration into the storage position or first configurationonce the actuated position has been reached and preferably once theinsertable element has been inserted into the body tissue.

The at least one element connected or connectable to the patch base,which may be used as an actuator for actuating an insertion motion,specifically when in the actuated position, may be flush with thehousing of the medical device. Thus, the at least one element connectedor connectable to the patch base may be flush with the remaining housingof the patch base, thereby, in conjunction with a housing of the patchbase, forming a smooth housing, without any protruding parts.Consequently, the at least one element connected or connectable to thepatch base may form or may contribute a part to the housing of themedical device. In the standby position, the part may protrude from thehousing, ready for being actuated by pushing it back into the housing,and in the actuated position, this part may be flush with the remaininghousing.

As outlined above, the medical device may further comprise at least oneremovable securing element, which may also be referred to as a safetyelement or as a safety lock. The securing element may be configured forsecuring the at least one element connected or connectable to the patchbase in the standby position. For removing the securing element, thesecuring element may fully be removed from the medical device or may bebrought into an unlocked position. The securing element may also becombined with other functions of the medical device. Thus, as anexample, the securing element may comprise at least one desiccant.

In addition or as an alternative to the linear sliding mechanism, asdiscussed above, a rotational mechanism may be used. The insertionmechanism may be configured to be driven by the rotational mechanism asdescribed above, specifically by a rotational movement of the elementconnected or connectable to the patch base, particularly via aconnecting force exerted when connecting the element to the patch base.Therefore, the insertion mechanism may comprise at least one pin. Theterm “pin” may specifically refer to a small, elongate element which mayspecifically be made of a stiff material. The pin may be engageableand/or driven by the at least one element connected or connectable tothe patch base. The insertion mechanism may be configured to be drivenby the connecting force exerted via the pin when connecting the elementto the patch base. Further, the pin may be connected to the patch viaone or more links. The term “link” may refer to a small, elongate objectwhich may be fixedly connected to at least two elements. Thus, the linkmay form a connection of the two elements. Specifically, the links maybe configured to be broken off from the patch before insertion. Thus,the drive unit may be triggered through a breakaway torque. Further,optionally, the insertion mechanism may comprise at least one spring.The spring may be configured to be driven by a spring load of thespring. The insertion mechanism, specifically the drive unit, maycomprise at least one flexible wire configured for driving and insertionof the insertable element. The flexible wire may be a flexible guidewire. One end of the flexible guide wire facing the insertion cannulamay be elastic and the other end of the flexible guide wire may bestiff.

The insertion mechanism may comprise at least one return spring. Theterm “return spring” may generally refer to an arbitrary elastic objectwhich is used to store mechanical energy. In case an object may becoupled to the return spring, the return spring may be configured to betensioned when the object is moved. Thereby, the return spring may beconfigured to move the object back to its original position when thereturn spring is relaxed. Specifically, the return spring may beconfigured to be tensioned during insertion of the insertable elementinto the body tissue. Further, the return spring may be configured tosupport a withdrawing of the insertion cannula from the body tissueafter insertion.

Further, the insertion cannula may be configured such that, afterinsertion, a tip of the insertion cannula is at least partially embeddedin material of the patch. Thereby, the insertable element may beprotected from the insertion cannula, specifically from the end of theinsertion cannula, which may comprise the slot.

Specifically, the insertion cannula may be a slotted cannula comprisingat least one axial slot that extends along the direction of extension ofthe insertion cannula and the insertable element may comprise at leastone protrusion. The term “protrusion” may generally refer to anarbitrary element or part of an object which protrudes from a surface ofthe object. The protrusion may at least partially protrude through theslot. The protrusion may be configured for preventing, at least to alarge extent, a displacement of the insertable element against adirection of insertion of the insertion cannula. The medical device maybe configured to hold the protrusion when retracting the insertioncannula from the body tissue, thereby preventing the insertable elementfrom being retracted from the body tissue.

The medical device may further comprise at least one holding down clamp.The term “holding down clamp” may generally refer to an arbitraryelement, which is configured to hold or secure an object in a certainposition in order to prevent an undesired movement or separation fromanother element, specifically through an application of an inwardpressure. The holding down clamp may be configured to prevent, at leastto a large extent, a withdrawing of the insertable element from the bodytissue after insertion. The holding down clamp may be configured topress onto the insertable element, thereby holding the insertableelement in the second configuration. Specifically, the holding downclamp may be identical to the protrusion as described above, or as willfurther be described below.

Additionally or alternatively, the insertable element may comprise oneor more clamps. As further used herein, the term “clamp” may refer to anobject which is configured to hold or to fix an element into a certainposition. The clamps may be located within an interior of the insertioncannula, specifically within the lumen of the insertion cannula.Specifically, the clamps may be configured to stick the insertableelement within the interior of the insertion cannula during insertion.The clamps may be configured to release the insertable element beforewithdrawing the insertion cannula. For example, the clamps may comprisearms protruding from the insertable element. The arms may engage with aninterior side of the wall of the cannula. The arms may enable theinsertable element to move in the direction of the proximal end andprevent the insertable element from moving in an opposite direction.

The medical device, as outlined above, may further comprise at least oneelectronics unit configured for interacting with the insertable element.As used herein, the term “electronics unit” generally refers to anarbitrary device having at least one electronic component. Specifically,the electronics unit may comprise at least one electronic component forone or more of performing a measurement with the sensor, performing avoltage measurement, performing a current measurement, recording sensorsignals, storing measurement signals or measurement data, transmittingsensor signals or measurement data to another device. The electronicsunit may specifically be embodied as a transmitter or may comprise atransmitter, for transmitting data. Other embodiments of the electroniccomponents are feasible.

The electronics unit may comprise at least one interconnect device,preferably a printed circuit board, more preferably a flexible printedcircuit board. The sensor may be “operably connected” to the electronicsunit. The term “operably connected” may specifically refer to a state,wherein two or more objects are connected to each other such that theycan interact with each other. Specifically, the sensor may be operablyconnected to the electronics unit such that sensor signals of the sensormay be transmitted to the electronics unit.

The electronics unit, e.g., in addition or as an alternative to theabove-mentioned sliding mechanism, may comprise at least one electronicsunit bayonet screw. The patch may comprise at least one patch bayonetcontour. The patch bayonet contour, in conjunction with the electronicsunit bayonet contour, may form a bayonet contour configured forestablishing a releasable mechanical connection between the electronicsunit and the patch. As generally used herein, the term “bayonet contour”refers to a component or part of an element which is configured tointeract with a counterpart bayonet contour in order to form a bayonetconnection or a bayonet connector. Thus, the patch bayonet contour andthe electronics unit bayonet contour may be complementary bayonetcontours configured for forming a bayonet connection or, in conjunction,a bayonet connector. Therein, one of the patch bayonet contour or theelectronics unit bayonet contour may be or may comprise a male bayonetcontour, such as a male bayonet plug, and the other one of the patchbayonet contour or the electronics unit bayonet contour may be or maycomprise a female bayonet contour, such as a female bayonet plug. Asgenerally used herein, a bayonet connector, also referred to as abayonet connection, may generally refer to an arbitrary connector orconnection between two bayonet contours in a bayonet fashion. Therein,generally, one or both of the bayonet contours involved may comprise atleast one protrusion and, in a complementary fashion, the other one ofthe bayonet contours may comprise at least one bayonet grove or bayonetslot in which the protrusion may be guided, such that two bayonetcontours interact in order to form the bayonet connection or bayonetconnector.

The electronics unit may further comprise at least two electricalcontacts. In a mated state, in which the releasable mechanicalconnection between the electronics unit and the patch is established bythe bayonet connector, an electrical connection between contacts locatedin the patch bayonet contour and the electrical contacts of theelectronics unit may be established. In a mated state, in which thereleasable mechanical connection between the electronics unit and thepatch is established by the bayonet connector, the electronics unit maybe pressed onto the patch or vice versa, by means of the bayonetconnector.

As used herein, the term “mechanical connection” generally refers to aconnection of two or more components by mechanical holding forces. As anexample, the mechanical connection may be or may comprise at least oneof a form-fit or a force-fit connection. In the case of the bayonetconnector or bayonet connection, specifically, the mechanical connectionmay be a form-fit connection. As further used herein, the term“releasable”, in the context of the mechanical connection, generallyrefers to the fact that the mechanical connection may be brought from adisconnected state, also referred to as a non-mated state, into aconnected state, also referred to as a mated state, and back into thedisconnected state. Thus, the mechanical connection may be closed andreleased at will. Specifically, the mechanical connection may bereleasable without using any tools, simply by manual action. As anexample, for opening the bayonet connector, forces of no more than 50 N,such as of no more than 20 N, such as of no more than 10 N, may berequired, which may be applied by one hand or even the fingers orfingertips of the user.

Further, the integrated insertion mechanism may be or may comprise alinear sliding mechanism. The term “linear sliding mechanism” may referto an arbitrary mechanism which is based on a linear sliding movement oftwo or more components relative to each other. Thereby, the term“sliding movement” may refer to a movement along in a continuousconnection with another element, specifically with a surface, morespecifically with a smooth surface, of the other element. Specifically,the linear sliding mechanism may comprise one or more interactingsliding elements, such as one or more guide rails or the like. Further,the term “linear sliding movement” may generally refer to a movementalong a straight line, e.g., within two dimensions. Specifically, theelectronics unit may comprise at least one linear sliding receptacle andthe patch comprises at least one linear sliding guide rail or viceversa. As further used herein, the terms “linear sliding receptacle” and“linear sliding guide rail” may refer to elements which arecomplementary to each other and which are configured to interact witheach other in order to realize the linear sliding mechanism. Forexample, the linear sliding guide rail is formed as a protrusion of thepatch or of the electronics unit and the linear sliding receptacle maybe part of the electronics unit. However, other embodiments may befeasible. Alternatively, the linear sliding guide rail may be part ofthe electronics unit and the linear sliding receptacle may be part ofthe patch. The linear sliding guide rail and the linear slidingreceptacle are shaped complementary to each other. For example, thelinear sliding receptacle and the linear guide rail may have an elongateshape and may extend along a longitudinal axis of the electronics unitand/or of the patch. The linear sliding receptacle and the linearsliding guide rail in conjunction may form a linear sliding connectorconfigured for establishing a releasable mechanical connection betweenthe electronics unit and the patch. The term “linear sliding connector”,also referred to as a linear sliding connection, may generally refer toan arbitrary connector or connection between two linear slidingcontours. Therein, generally, one or both of the linear sliding contoursinvolved may comprise at least one protrusion and, in a complementaryfashion, the other one of the linear sliding contours may comprise atleast one linear sliding grove or linear sliding slot in which theprotrusion may be guided in order to form the linear sliding connectionor linear sliding connector.

The linear sliding mechanism may comprise the return spring as describedabove or as will further be described below in more detail. For example,the return spring may be located next to the insertion cannula. Thereturn spring may be fixedly connected to the drive arm via at least oneconnector element such as a cannula sleeve.

Specifically, one end of the return spring may be attached to thecannula sleeve and the cannula sleeve may further be attached,specifically fixedly attached, to the drive arm as described above or aswill further be described below in more detail. Further, the insertableelement may be fixedly attached to the drive arm, specifically via atleast one fixation element. Specifically, the fixed end may be locatedon one end of the drive arm and the cannula sleeve may be connected tothe opposing end of the drive arm. The drive arm may be configured to bemovable in a linear direction when the linear sliding mechanism isapplied, thereby inserting the insertion cannula and the insertableelement into the body tissue. Further, the return spring may beconfigured to be compressed when inserting the insertion cannula and theinsertable element into the body tissue. Moreover, the cannula sleevemay be configured to be moveable in a linear fashion when the returnspring relaxes, thereby withdrawing the drive arm.

Further, the insertion cannula may be at least partially received withinthe return spring when the return spring is in an outstretchedconfiguration. Specifically, the return spring and the insertion cannulamay be at least partially received in a receptacle of the patch.Further, the return spring, specifically one of the ends of the returnspring, is attached to the cannula sleeve and the insertion cannula isfixedly attached to the cannula sleeve. The cannula sleeve may beconfigured to be moveable in a linear fashion, thereby compressing thereturn spring. Further, the cannula sleeve may be configured to bemoveable in a linear fashion, thereby inserting the insertion cannulainto the body tissue or withdrawing the insertion cannula from the bodytissue.

In a further aspect of the invention, an analyte measurement device fordetecting at least one analyte in a body fluid is disclosed. The analytemeasurement device comprises at least one medical device according tothe present invention, e.g., as described above or as will further bedescribed below. The insertable element comprises at least one analytesensor for detecting the at least one analyte in the body fluid.Further, the analyte measurement device has at least one evaluationdevice interacting with the analyte sensor.

As further used herein, the term “analyte measurement device” generallyrefers to an arbitrary device configured for conducting at least oneanalytical measurement. The analytical measurement device may preferablybe an electronic device. The analyte measurement device may be adaptedto interact with the medical device, specifically with the insertableelement, more specifically with the analyte sensor in order to derive atleast one item of information about the analyte of the sample.Specifically, the analyte measurement device may be adapted to detect atleast one signal produced by the analyte. Thus, the analyte measurementdevice may comprise at least one electronic evaluation device in orderto derive the at least one item of information about the analyte fromthe at least one signal. Thus, the analyte measurement device maycomprise at least one evaluation unit comprising at least one dataprocessing device, such as a microcontroller.

In a further aspect of the present invention, a medication device fordelivering at least one medication to a user is disclosed. The term“medication device” generally refers to an arbitrary device which hisconfigured to deliver a drug and/or a therapeutic agent via a specificroute of administration. Such devices are commonly used as part of oneor more medical treatments.

The medication device comprises at least one medical device according tothe present invention, e.g. as described above or as will further bedescribed below. The insertable element comprises at least one of aninfusion cannula or a dosing tube. The medication device furthercomprises at least one medication pump fluidly coupled to the insertableelement. The term “medication pump” generally refers to an arbitrarypump which is configured to move a drug and/or a therapeutic agent bymechanical action. Specifically, the medication pump may be an infusionpump which is configured to infuse an arbitrary medication into apatient's circulatory system. Generally, the infusion pump may beconfigured to be applied intravenously or subcutaneously. However, otherapplications are feasible. The term “fluidly coupled” may generallyrefer to a property of two or more elements such that an arbitrary fluidmay be transferable between the two or more elements.

In a further aspect of the present disclosure, a method fortranscutaneously inserting an insertable element into a body tissue isdisclosed. The method comprises the method steps as listed as follows.The method steps may be performed in the given order. However, otherorders of the method steps are feasible. Further, one or more of themethod steps may be performed in parallel and/or on a timely overlappingfashion. Further, one or more of the method steps may be performedrepeatedly. Further, additional method steps may be present which arenot listed.

The method comprises:

-   -   a) providing at least one medical device according to the        present disclosure, such as described above or as will further        be described below, the medical device having at least one        electronics unit and at least one patch configured to be mounted        onto a skin of the user, the patch having a patch base;    -   b) placing the patch base onto the skin; and    -   c) inserting the insertable element into the body tissue.

The electronics unit may fully or partially be provided as a separatecomponent. Specifically, the electronics component may be connected tothe patch base before step c) of the method may be conducted. Thereby,the inserting of the insertable element into the body tissue may betriggered and/or conducted by the electronics unit such as by arotational movement or a translational movement of the electronics unit.Additionally or alternatively, the electronics unit may also fully orpartially be integrated into the patch, such as by the electronics unitand the patch being provided as one unit. Thereby, as an example, theinserting of the insertable element into the body tissue may also betriggered and/or conducted by the electronics unit such as by therotational movement or the translational movement of the electronicsunit. Moving the electronics unit such as rotationally ortranslationally may also be referred to as closing the patch,specifically the patch base.

The medical device may be provided in a sterile packaging before usage.The term “packaging” may refer to an arbitrary object which isconfigured for fully or partially enclosing or encasing at least oneother component, wherein the at least one other component, as anexample, may be a component which requires protection, such asmechanical protection and/or protection against moisture and/ormicrobial contaminations. The term “sterile” may generally refer to aproperty of an arbitrary object of being, at least to a large extent,free from all forms of life and/or other biological agents such asprions, viruses, fungi, bacteria or spore forms. Thus, the sterileobject may be treated by at least one sterilization process thatreduces, eliminates and/or deactivates the forms of life and/or theother biological agents. The sterilization process may comprise one ormore of the following techniques: heating, chemical treatment,irradiation, high pressure, filtration. However, other techniques arefeasible. The sterilization process may be conducted within a specifiedregion or area of the object such as a surface of the object.

The patch base may be fixedly connected to the sterile packaging,particularly via adhesion. The sterile packaging may be adhered to atleast one adhesive surface, preferably to at least one plaster beforeopening the sterile packaging, wherein sterile packaging is opened viaat least one predetermined opening and at least partially removed fromthe medical device along edges of the patch base. Inserting theinsertable element into the body tissue may be conducted via one or moreof the rotational movement of the electronics unit or the translationalmovement of the electronics unit with respect to the patch base. In casethe electronics unit and the patch base are provided as one unit, asdescribed above, the electronics unit may open a sterile barrier of thepatch base and may further connect to the insertable element,specifically to the sensor, in the base plate. The sterile barrier maybe part of the sterile packaging.

The proposed medical device, the analyte measurement device, themedication device and the proposed method for transcutaneously insertingan insertable element into a body tissue provide many advantages overknown devices and methods.

Specifically, as compared, e.g., to vertical inserters, the integratedinsertion mechanism according to the present disclosure, specificallythe sliding mechanism, allows for designing a very small medical device.A compact design may be realized which also may consider requirementsfor new generation products and which also may take a concept ofplatform design into account. Specifically, the concept of the presentinvention may allow for designing a “horizontal system”, such as ahorizontal continuous glucose monitoring system or a horizontal drugadministration device. Very small sterile compartments may be realized,e.g., with a sensor and a cannula. Generally, the integrated insertionmechanism, specifically the sliding mechanism, may allow for anapplication of the insertion cannula with less force on the skin ascompared to conventional systems. Further, the insertion cannula may becompletely guided during the insertion mechanism, e.g., through a verysmall insertion hole in the patch base. Further, a shape ratio of theinsertable element, e.g., the sensor and/or the infusion cannula, to across-section of the insertion cannula may be improved as compared toconventional systems. Further, the patch may be designed in a verycompact and small fashion as compared to conventional systems.

Commonly, current medical devices generally comprise a furtherconstruction unit. The further construction unit may be or may comprisea separate inserter or a separate insertion element. The inserter mayhave to be manufactured as an additional construction unit and maycomprise several component parts. The inserter may be too large so thatthe inserter may not be configured to stay on the patient's skin duringapplication of the medical device. Moreover, the inserter generally hasto be packaged separately. Further, a disposal of the inserter has to beconducted separately, specifically as a potentially contaminated medicalproduct. Through the large design of the inserter, high costs forsterilization may emerge, specifically if the inserter has to besterilized as well. Moreover, in some fields of application, theinserter may not be applicable for all points of application. Commonly,the analyte sensor may have a rectangular shape. Consequently, anapplication of round insertion cannulas may lead to an unfavorablegeometric relation with regard to a puncture area.

Usually, common medical devices may initially comprise at least twocomponents. The two components may form a final product afterapplication of the medical device to the body tissue of the user. Theanalyte sensor may commonly have to be connected to the electronics unitvia the user. This may specifically lead to errors during applicationand thus to severe consequences such as measurement errors. Therefore,in common medical devices, elaborate constructions may generally berequired to circumvent error sources. The elaborate constructions mayexemplarily comprise seals, electrical contacts or locking forces.

On the contrary, by applying the medical device according to the presentdisclosure, the user may receive an “all-in-one” medical device withouta need for assembling the medical device. The insertion mechanism may beintegrated within the medical device. Consequently, no additionalinserter or insertion element may be required and further constructioncomponents as well as an assembling of the further constructioncomponents may be dropped. The medical device may further be robust andlow-priced. An application of the medical device to the body tissue ofthe user may be conducted in a simple and intuitive manner.

The medical device may comprise the insertion cannula, specifically withan, at least to a large extent, essentially rectangular shape. Theinsertion cannula may be received in the patch of the medical device.Through the rectangular shape of the insertion cannula, the geometricrelation between the cross-section of the analyte sensor and thecross-section of the insertion cannula may optimally be used.

In the first configuration, the insertion cannula may be stored insidethe patch and may specifically have an at least essentially straightconfiguration. This may specifically be supported by the rectangularshape of the insertion cannula. Thereby, the insertion cannula mayspecifically be a flat insertion cannula and the insertion cannula maybe supported by the patch, specifically by the patch base.

The insertion mechanism may be configured for driving the insertioncannula. Further, the insertion mechanism may comprise the return springwhich is configured to support a withdrawing of the insertion cannula.The drive unit of the insertion mechanism may specifically be triggeredor driven via the rotational mechanism. The rotational mechanism may betriggered via the electronics unit. The electronics unit may beconnected to the patch, specifically to the patch base, via the bayonetcontour. Via a rotational movement of the electronics unit, the patch,specifically the patch base may be closed. Further, the electronics unitmay be configured to seal the analyte sensor against the patch. Thepatch base may comprise the passage opening. Via applying the rotationalmechanism, specifically by closing the patch, the insertion cannula maybe inserted into the body tissue of the user or the patient. Thereby,the insertion cannula may be put through the passage opening of thepatch base. The insertion cannula may be transferred into the secondconfiguration. Specifically, the insertion cannula may have the archform, specifically with an angle of 45° to the patch base. The patch maycomprise a board, specifically a circuit board, with electricalcontacts. The board may be configured to realize an electricalconnection between the analyte sensor and the electronics unit.

The integrated insertion mechanism, as outlined above, specifically maybe or may comprise a sliding mechanism, specifically a linear slidingmechanism which specifically may be actuated by connecting anelectronics unit to the patch and/or by moving the electronics unitrelative to the patch. Additionally or alternatively, however, theintegrated insertion mechanism may also be or may also comprise arotational insertion mechanism. As an example, a rotational force may betransferred to the insertion cannula by a rotational movement of theelectronics unit relative to the patch base, e.g., via a flexible wire.Specifically, the insertion mechanism may comprise a pin. The pin may beconfigured to exert the connecting force involving the wire and theelectronics unit. The flexible wire may be configured to trigger theinsertion cannula. Further, the patch, specifically the patch base, maycomprise the return spring. The return spring may be configured to betensioned during insertion of the insertion cannula into the bodytissue. To trigger the insertion cannula, the return spring may beconfigured to support a withdrawing of the insertion cannula from thebody tissue after insertion. Specifically, the return spring may betensioned during applying the rotational mechanism, specifically duringclosing the patch via the electronics unit.

The insertable element may comprise at least one protrusion. Theprotrusion may extend through the axial slot of the insertion cannula.Further, the protrusion may be configured to be attached to the patch,specifically to the patch base, and thus to prevent, or at least toreduce, at least partially a movement of the insertable element againstthe direction of insertion. Further, the protrusion may be configured tohold the insertable element after insertion, specifically in order toprevent the insertable element from being retracted from the bodytissue. Further, a connection between the protrusion and the patch basemay be disconnected, such that the analyte sensor may stay within thebody tissue of the user or the patient.

In case the insertion cannula is a closed cannula, i.e. a cannulawithout any axial slots or openings, a coupling between the insertableelement and the insertion cannula has to be ensured. Thereby, theinsertable element may comprise the clamps, which are configured tostick the insertable element within the interior of the insertioncannula during insertion. Other clamps may be configured to release theinsertable element before withdrawing the insertion cannula.

The medical device may be provided in a sterile packaging before usage.Thereby, the patch may be fixedly connected to the sterile packaging.The sterile packaging may be adhered to at least one adhesive surface ofthe patch, specifically of the patch base. After sterilizing thepackage, the package may be adhered to at least one adhesive surface,preferably to at least one plaster. The sterile packaging may comprisethe at least one predetermined opening and the sterile packaging may beconfigured to be at least partially removed from the medical devicealong the edges of the patch base. One part of the sterile packaging mayremain between the patch base and the adhesive surface, specifically theplaster. Consequently, the sterile packaging may be fully integratedinto the medical device. Specifically, the medical device may onlyrequire a small volume during sterilization. Optionally, the sterilepackaging may be configured to be openable by closing the patch asdescribed above.

A number of handling steps during transcutaneously inserting theinsertable element into the body tissue may be reduced. A size of thesterile packaging, specifically of the sterile packaging comprising theentire medical device, may be reduced to the size of a matchbox.

In the medication device, the dosing tube may be received in theinsertion cannula. Thereby, the insertion cannula may specifically be aslotted cannula and/or a semi-circular shaped cannula. Further, themedication device may comprise the medication device fluidly coupled tothe insertable element.

After inserting of the insertable element, specifically the sensor, theinsertion cannula may be withdrawn into the patch such as via a reversepulling mechanism, specifically into a receptacle such as a guidancereceptacle. Further, the insertion cannula may be withdrawn from theinsertable element, specifically the sensor, into a free volume withinthe patch via a direction change with a reverse pulling mechanism. Theconstruction volume may even be further reduced in case the insertioncannula is integrated into the return spring of the integrated insertionmechanism. When applying the linear sliding mechanism as describedabove, or as will further be described below, the sterile packaging maybe opened while inserting the insertable element into the body tissue.Thereby, the electronics unit may be mounted onto the patch.Consequently, a number of method steps may be reduced. Specifically, themethod for transcutaneously inserting an insertable element into thebody tissue may be reduced to three method steps. Further, the sterilepackaging for the medical device may be reduced. Moreover, the medicaldevice may comprise an insertion device having the insertion cannulawhich may be removed after inserting the insertable element into thebody tissue. Thereby, a size of the patch may be reduced.

Summarizing the findings of the present disclosure, the followingembodiments are advantageous:

Embodiment 1

A medical device for transcutaneously inserting an insertable elementinto a body tissue, wherein the medical device comprises:

-   -   at least one insertable element, wherein the insertable element        comprises at least one in vivo distal end for subcutaneous        insertion and at least one ex vivo proximal end;    -   at least one insertion cannula for subcutaneously inserting the        insertable element, the insertion cannula having a lumen which        fully or partially is enclosed by a wall of the insertion        cannula, wherein the insertable element is received in the        lumen, wherein the insertion cannula is a pre-bended insertion        cannula,        wherein the medical device further comprises at least one patch,        configured to be mounted onto the skin of a user, wherein the        patch comprises a patch base, wherein the patch comprises an        integrated insertion mechanism for driving the insertion cannula        from a storage position within the patch into an inserted        position within the body tissue on a curved insertion path.

Embodiment 2

The medical device according to the preceding embodiment, wherein theinsertion cannula is at least partially made of a material selected fromthe group consisting of: steel, specifically stainless steel; a plasticmaterial, specifically a flexible plastic material.

Embodiment 3

The medical device according to any one of the preceding embodiments,wherein the insertion cannula is pre-bended in such a way that theinsertion cannula at least partially has the shape of a segment of acircle.

Embodiment 4

The medical device according to the preceding embodiment, wherein theinsertion path, at least partially, is shaped as a segment of a circle.

Embodiment 5

The medical device according to any one of the preceding embodiments,wherein the lumen has a rectangular cross-section.

Embodiment 6

The medical device according to the preceding embodiment, wherein theinsertion cannula is a slotted insertion cannula, with a slot located ata short side of the rectangular cross-section.

Embodiment 7

The medical device according to any one of the preceding embodiments,wherein the insertion cannula is selected from the group consisting of:a closed cannula with the wall circumferentially enclosing the lumen; aslotted cannula, with the insertion cannula having a slot extending inan axial direction.

Embodiment 8

The medical device according to any one of the preceding embodiments,wherein the insertion cannula at least partially has an essentiallyrectangular cross-section.

Embodiment 9

The medical device according to any one of the preceding embodiments,wherein the insertion cannula at least partially has an asymmetricshape.

Embodiment 10

The medical device according to any one of the preceding embodiments,wherein the insertion cannula is at least partially made of at least onebiocompatible material.

Embodiment 11

The medical device according to any one of the preceding embodiments,wherein the medical device is configured such that the insertion cannulais withdrawn into the medical device after insertion of the insertableelement.

Embodiment 12

The medical device according to the preceding embodiment, wherein theinsertable element is configured to stay at least partially within thebody tissue after the insertion cannula is withdrawn into the medicaldevice.

Embodiment 13

The medical device according to the preceding embodiment, wherein theinsertion cannula is a slotted cannula comprising at least one axialslot that extends along the major axis of the insertion cannula, whereinthe insertable element comprises at least one protrusion, wherein theprotrusion at least partially protrudes through the slot.

Embodiment 14

The medical device according to the preceding embodiment, wherein theprotrusion is configured for preventing, at least to a large extent, adisplacement of the insertable element against a direction of insertionof the insertion cannula.

Embodiment 15

The medical device according to any one of the two precedingembodiments, wherein the medical device is configured to hold theprotrusion when retracting the insertion cannula from the body tissue,thereby preventing the insertable element from being retracted from thebody tissue.

Embodiment 16

The medical device according to any one of the preceding embodiments,wherein the medical device further comprises at least one holding downclamp, wherein the holding down clamp is configured to prevent, at leastto a large extent, a withdrawing of the insertable element from the bodytissue after insertion.

Embodiment 17

The medical device according to any one of the preceding embodiments,wherein the insertable element comprises one or more clamps, wherein theclamps are configured to stick the insertable element within an interiorof the insertion cannula during insertion, wherein the clamps areconfigured to release the insertable element before withdrawing theinsertion cannula.

Embodiment 18

The medical device according to the preceding embodiment, wherein theclamps comprise arms protruding from the insertable element, the armsengaging with an interior side of the wall of the cannula, the armsenabling the insertable element to move in the direction of the proximalend of preventing the insertable element from moving in an oppositedirection.

Embodiment 19

The medical device according to any one of the preceding embodiments,wherein the insertable element is selected from the group consisting of:a sensor, specifically a biosensor, preferably an analyte sensor fordetecting at least one analyte in a body fluid; a sensor configured forremaining under the skin after removing the insertion cannula; aninfusion cannula; a dosing tube.

Embodiment 20

The medical device according to the preceding embodiment, wherein theinfusion cannula is part of an infusion kit, the infusion kit furthercomprising at least one fluid coupling for coupling the infusion kit toat least one medication device, preferably to at least one medicationpump.

Embodiment 21

The medical device according to any one of the preceding embodiments,wherein the insertable element is, at least to a large extent, made ofan elastic material.

Embodiment 22

The medical device according to any one of the preceding embodiments,wherein the insertable element is configured to be removed from the bodytissue subsequent to an expiration of a useful lifetime of the medicaldevice.

Embodiment 23

The medical device according to any one of the preceding embodiments,wherein the insertion cannula is at least partially connected to thepatch base and/or placed inside the patch base.

Embodiment 24

The medical device according to any one of the preceding embodiments,wherein the integrated insertion mechanism comprises at least one driveunit, wherein the drive unit is configured to urge the insertion cannulain a direction of insertion, preferably by pushing or pulling theinsertion cannula.

Embodiment 25

The medical device according to the preceding embodiment, wherein thedrive unit is triggered or driven via a rotational mechanism.

Embodiment 26

The medical device according to any one of the preceding embodiments,wherein the integrated insertion mechanism is a linear slidingmechanism.

Embodiment 27

The medical device according to any one of the preceding embodiments,wherein the medical device further comprises at least one elementconnected or connectable to the patch base, preferably at least oneelement interacting with the insertable element, preferably one of anelectronics unit or a medication pump, particularly via a force-fitconnection, wherein the insertion mechanism is configured to be drivenby a connecting force exerted when connecting the element to the patchbase or when moving the element relative to the patch base.

Embodiment 28

The medical device according to the preceding embodiment, wherein the atleast one element connected or connectable to the patch base comprisesat least one linear sliding receptacle and the patch comprises at leastone linear sliding guide rail or vice versa, wherein the linear slidingreceptacle and the linear sliding guide rail in conjunction form alinear sliding connector configured for moving the element relative tothe patch base or for establishing a releasable mechanical connectionbetween the at least one element connectable to the patch base and thepatch.

Embodiment 29

The medical device according to any one of the two precedingembodiments, wherein the at least one element connected or connectableto the patch base comprises at least one element selected from the groupconsisting of: an electronics unit configured for interacting with theinsertable element; a slider, specifically a U-shaped slider; a bracket,specifically a U-shaped bracket.

Embodiment 30

The medical device according to any one of the three precedingembodiments, wherein the at least one element connected or connectableto the patch base is configured to be brought from a standby positioninto an actuated position, specifically by a pushing motion, wherein themedical device is configured to insert the insertion cannula into thebody tissue when the at least one element connectable to the patch baseis brought into the actuated position.

Embodiment 31

The medical device according to the preceding embodiment, wherein themedical device is further configured for retracting the insertioncannula once the actuated position has been reached.

Embodiment 32

The medical device according to any one of the two precedingembodiments, wherein the medical device further comprises at least oneremovable securing element, wherein the securing element is configuredfor securing the at least one element connected or connectable to thepatch base in the standby position.

Embodiment 33

The medical device according to the preceding embodiment, wherein thesecuring element comprises at least one desiccant.

Embodiment 34

The medical device according to any one of the four precedingembodiments, wherein the at least one element connected or connectableto the patch base, when in the actuated position, is flush with ahousing of the medical device.

Embodiment 35

The medical device according to any one of the preceding embodiments,wherein the integrated insertion mechanism, specifically the drive unit,comprises at least one flexible wire configured for driving andinsertion of the insertable element.

Embodiment 36

The medical device according to the preceding embodiment, wherein theflexible wire is a flexible guide wire, wherein one end of the flexibleguide wire facing the insertion cannula is elastic and wherein the otherend of the flexible guide wire is stiff.

Embodiment 37

The medical device according to any one of the preceding embodiments,wherein the integrated insertion mechanism comprises at least one returnspring, wherein the return spring is configured to support a withdrawingof the insertion cannula from the body tissue after insertion.

Embodiment 38

The medical device according to the preceding embodiment, wherein thereturn spring is configured to be tensioned during insertion of theinsertable element into the body tissue.

Embodiment 39

The medical device according to any one of the preceding embodiments,wherein the patch comprises at least one passage opening, wherein theinsertion cannula is movable from the patch into the body tissue throughthe passage opening and vice versa.

Embodiment 40

The medical device according to the preceding embodiment, wherein ashape of the passage opening corresponds to a shape of the insertioncannula.

Embodiment 41

The medical device according to any one of the preceding embodiments,wherein the insertion cannula is configured such that, after insertion,a tip of the insertion cannula is at least partially embedded inmaterial of the patch.

Embodiment 42

The medical device according to any one of the preceding embodiments,wherein the medical device further comprises at least one electronicsunit configured for interacting with the insertable element.

Embodiment 43

The medical device according to the preceding embodiment, wherein theelectronics unit comprises at least one electronics unit bayonet screw,wherein the medical device further comprises at least one patch, whereinthe patch comprises at least one patch bayonet contour, wherein thepatch bayonet contour and the electronics unit bayonet screw, inconjunction, form a bayonet connector configured for establishing areleasable mechanical connection between the electronics unit and thepatch.

Embodiment 44

The medical device according to the preceding embodiment, wherein theelectronics unit further comprises at least two electrical contacts,wherein, in a mated state in which the releasable mechanical connectionbetween the electronics unit and the patch is established by the bayonetconnector, an electrical connection between contacts located in thepatch bayonet contour and the electrical contacts of the electronicsunit is established.

Embodiment 45

The medical device according to any one of the two precedingembodiments, wherein in a mated state in which the releasable mechanicalconnection between the electronics unit and the patch is established bythe bayonet connector, the electronics unit is pressed onto the patch,or vice versa, by means of the bayonet connector.

Embodiment 46

The medical device according to any one of the four precedingembodiments, wherein the integrated insertion mechanism is a linearsliding mechanism, wherein the electronics unit comprises at least onelinear sliding receptacle and the patch comprises at least one linearsliding guide rail, or vice versa, wherein the linear sliding receptacleand the linear sliding guide rail, in conjunction, form a linear slidingconnector configured for establishing a releasable mechanical connectionbetween the electronics unit and the patch.

Embodiment 47

The medical device according to the preceding embodiment, wherein thelinear sliding guide rail is formed as a protrusion of the patch or ofthe electronics unit.

Embodiment 48

The medical device according to any one of the two precedingembodiments, wherein the linear sliding guide rail and the linearsliding receptacle are shaped complementary to each other.

Embodiment 49

The medical device according to any one of the three precedingembodiments, wherein the linear sliding receptacle and the linearsliding guide rail may have an elongate shape and may extend along alongitudinal axis of the electronics unit.

Embodiment 50

The medical device according to any one of the four precedingembodiments, wherein the insertable element may be fixedly attached to adrive arm, specifically via at least one fixation element.

Embodiment 51

The medical device according to the preceding embodiment, wherein thedrive arm is configured to be movable in a linear direction when thelinear sliding mechanism is applied, thereby inserting the insertioncannula and the insertable element into the body tissue.

Embodiment 52

The medical device according to any one of the six precedingembodiments, wherein the linear sliding mechanism comprises at least onereturn spring, which is configured to be compressed when inserting theinsertion cannula and the insertable element into the body tissue.

Embodiment 53

The medical device according to the preceding embodiment, wherein thereturn spring is located next to the insertion cannula.

Embodiment 54

The medical device according to any one of the two precedingembodiments, wherein the insertion cannula is at least partiallyreceived within the return spring when the return spring is in anoutstretched configuration.

Embodiment 55

The medical device according to the preceding embodiment, wherein oneend of the return spring is attached to a cannula sleeve, wherein theinsertion cannula is fixedly attached to the cannula sleeve.

Embodiment 56

The medical device according to the preceding embodiment, wherein thecannula sleeve is configured to be moveable in a linear fashion, therebyinserting the insertion cannula into the body tissue or withdrawing theinserting cannula from the body tissue.

Embodiment 57

An analyte measurement device for detecting at least one analyte in abody fluid, the analyte measurement device comprising at least onemedical device according to any one of the preceding embodiments,wherein the insertable element comprises at least one analyte sensor fordetecting the at least one analyte in the body fluid, the analytemeasurement device further having at least one evaluation deviceinteracting with the analyte sensor.

Embodiment 58

A medication device for delivering at least one medication to a user,the medication device comprising at least one medical device accordingto any one of the preceding embodiments referring to a medical device,wherein the insertable element comprises at least one of an infusioncannula or a dosing tube, wherein the medication device furthercomprises at least one medication pump fluidly coupled to the insertableelement.

Embodiment 59

A method for transcutaneously inserting an insertable element into abody tissue, wherein the method comprises:

-   -   providing at least one medical device according to any one of        the preceding embodiments referring to a medical device, the        medical device having at least one electronics unit and at least        one patch configured to be mounted onto the skin of a user, the        patch having a patch base;    -   placing the patch base onto the skin; and    -   inserting the insertable element into the body tissue.

Embodiment 60

The method according to the preceding embodiment, wherein the medicaldevice is provided in a sterile packaging before usage.

Embodiment 61

The method according to the preceding embodiment, wherein the patch baseis fixedly connected to the sterile packaging, particularly viaadhesion.

Embodiment 62

The method according to the preceding embodiment, wherein the sterilepackaging is adhered to at least one adhesive surface, preferably to atleast one plaster before opening the sterile packaging, wherein sterilepackaging is opened via at least one predetermined opening and at leastpartially removed from the medical device along edges of the patch base.

Embodiment 63

The method according to any one of the preceding method embodiments,wherein inserting the insertable element into the body tissue isconducted via one or more of a rotational movement of the electronicsunit or a translational movement of the electronics unit with respect tothe patch base.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned aspects of exemplary embodiments will become moreapparent and will be better understood by reference to the followingdescription of the embodiments taken in conjunction with theaccompanying drawings, wherein:

FIGS. 1A, 1B and 1C show an exemplary embodiment of a medical device indifferent perspective views;

FIGS. 2A and 2B show exemplary embodiments of a medical device indifferent perspective views;

FIG. 3 shows an exemplary embodiment of a medical device in aperspective view;

FIGS. 4A, 4B, 4C and 4D show an exemplary method for transcutaneouslyinserting an insertable element into a body tissue;

FIGS. 5A, 5B, 5C, 5D, 5E, 5F and 5G show a further exemplary embodimentof a medical device in perspective views (FIGS. 5A, 5C, 5E), incross-sectional views (FIGS. 5B, 5D, 5F) and in an enlarged sectionalview (FIG. 5G);

FIGS. 6A, 6B and 6C show a further exemplary method for transcutaneouslyinserting an insertable element into a body tissue;

FIGS. 7A and 7B show a further exemplary embodiment of a medical devicein different perspective views;

FIGS. 8A and 8B show a further exemplary embodiment of a medical devicein different perspective views;

FIGS. 9A and 9B show a further exemplary embodiment of a medical devicein different perspective views;

FIGS. 10A and 10B show a further exemplary embodiment of a medicaldevice in different perspective views;

FIGS. 11A and 11B show a further exemplary embodiment of a medicaldevice in different perspective views;

FIGS. 12A and 12B show a further exemplary embodiment of a medicaldevice in different perspective views;

FIGS. 13A, 13B, 13C, 13D and 13E show a further exemplary embodiment ofa medical device in different perspective views;

FIG. 14 shows a further exemplary embodiment of an insertion cannula;and

FIGS. 15A, 15B, 15C, and 15D show a further exemplary embodiment of amedical device.

DESCRIPTION

The embodiments described below are not intended to be exhaustive or tolimit the invention to the precise forms disclosed in the followingdescription. Rather, the embodiments are chosen and described so thatothers skilled in the art may appreciate and understand the principlesand practices of this disclosure.

FIGS. 1A to 1C show an exemplary embodiment of a part of a medicaldevice 108 in different perspective views. The medical device 108further comprises at least one patch, which will be explained in anexemplary fashion in further details in the embodiments below. Themedical device 108 comprises at least one pre-bended insertion cannula110 and at least one insertable element 112. The pre-bended insertioncannula 110, in FIG. 1A, is shown in a flat shape, which is taken, e.g.,due to external forces exerted onto the insertion cannula 110, as willbe outlined in further detail below.

The insertion cannula 110 may specifically have an elongate shape.Further, the insertion cannula 110 may at least partially have anessentially rectangular shape, specifically a rectangular cross-section.Specifically, the insertion cannula 110 may be a slotted cannula 114.One end 116 of the insertion cannula 110 may comprise one slot 118configured for facilitating an insertion of the insertion cannula 110into a body tissue of a user or a patient. Specifically, the slot 118may form an angle of to 10° to 80°, more preferably of 20° to 60°, to alongitudinal axis 120 of the insertion cannula 110, as depicted in FIG.1A. Further, the slotted cannula 114 may have a slot 128 extending in anaxial direction 130, specifically extending along the longitudinal axis120 of the insertion cannula 110. The axial direction 130 may correspondto a direction of extension 132 of the insertion cannula 110. As willfurther be described below and as specifically depicted in FIGS. 1B and1C, the insertion cannula 110 is transformable. Thus, the longitudinalaxis 120 may be a major axis 134 and the insertion cannula 110 may beconfigured to be transformable along the major axis 134.

The insertion cannula 110 has a lumen 122 which is partially enclosed bya wall 124 of the insertion cannula 110. The wall 124 of the insertioncannula 110 specifically may comprise or may fully be made of stainlesssteel. The insertion cannula 110 is stored in a first configuration 136,as depicted in FIG. 1A. The first configuration 136 may correspond to anessentially straight shape 138 and/or to an essentially flat shape 140of the insertion cannula 110. As will be outlined in further detailbelow, a rounded or curved shape is also possible.

The insertable element 112 comprises at least one in vivo distal end 142and at least one ex vivo proximal end 144. The in vivo distal end 142 isconfigured for subcutaneous insertion. The insertable element 112 is atleast partially received in the lumen 122 of the insertion cannula 110.Specifically, the in vivo distal end 142 may be received in the lumen122 of the insertion cannula 110. The insertable element 112 may have anessentially elongate shape and may specifically have a cross-sectionwhich is adapted to the cross-section of the insertion cannula 110.Thus, the insertable element 112 may specifically have a rectangularcross-section. For example, the insertable element 112 may be a sensor146, specifically an analyte sensor 148. The sensor 146 may beconfigured to be electrically connectable to an electronics unit (notshown). Thus, the sensor 146 may comprise a contact portion 150. Thecontact portion 150 may specifically be located at the ex vivo proximalend 144.

While the insertion cannula 110 is stored in the first configuration136, as depicted in FIG. 1A, the shape of the insertable element 112 maycorrespond to the first configuration 136 of the insertion cannula 110.This first configuration may be taken when the insertion cannula 110 isin a storage position of a patch, as will be outlined in further detailbelow. Thus, the insertable element 112, specifically at least the invivo distal end 142 of the insertable element 112, may be straight andextend along the major axis 134 of the insertion cannula 110 as well.Further, the insertable element 112 may comprise a middle part 152. Themiddle part 152 may refer to a part of the insertable element 112located between the in vivo distal end 142 of the insertable element 112and the ex vivo proximal end 144 of the insertable element 112. Whilethe insertion cannula 110 is stored in the first configuration 136, themiddle part 152 of the insertable element 112 may have a curved shape154.

Further, the insertable element 112 may comprise at least one protrusion156. The protrusion 156 may at least partially protrude through the slot128. The protrusion 156 may be configured for preventing, at least to alarge extent, a displacement of the insertable element 112 against adirection of insertion 158 of the insertion cannula 112. Specifically,the protrusion 156 may be configured to be movably fixed onto a surface(not shown), wherein the insertable element 112 is movable parallel tothe surface.

As depicted in FIG. 1B, the insertion cannula 110 is configured to betransferred into a second configuration 160 for insertion. This secondconfiguration may be taken by the cannula 110 in an inserted positionwithin the body tissue, as will be outlined in further detail below. Thesecond configuration 160 may correspond to a pre-programmedconfiguration 162. Thus, the insertion cannula 110 is a pre-bendedinsertion cannula 110, and the second configuration may be the naturalbended configuration, whereas the first configuration may be a straightor less bended configuration into which the insertion cannula 110 has tobe forced. Specifically, when the insertion cannula 110 is transformedto the second configuration 160, the insertion cannula 110 may compriseat least one curvature 164. More specifically, when in the secondconfiguration 160, the insertion cannula 110 may have an arch form 166.Thereby, the insertion cannula 110, specifically the end 116 of theinsertion cannula 110, may have an angle of 0° to 90°, specifically 30°to 50°, to the major axis 134.

The insertable element 112 may be made of a flexible material.Therefore, when the insertion cannula 110 is transformed into the secondconfiguration 160, the insertable element 112 may be configured to adaptto the second configuration 160 of the insertion cannula 110. Thus, theinsertable element 112, specifically the in vivo distal end 142 of theinsertion cannula 110, may have an arch form 168 corresponding to thearch form 166 of the insertion cannula 110. Further, the middle part 152of the insertable element 112 may be configured to elongate when theinsertion cannula 110 is transformed into the second configuration 160.Specifically, both the first configuration 136 and the secondconfiguration 160 may be bended configurations, with a bending radius inthe first configuration 136 preferably being larger than a bendingradius in the second configuration 160. As an example, the insertioncannula 110 may be a flexible pre-bended cannula, e.g. made of stainlesssteel, with a rectangular cross-section. In absence of external forces,the insertion cannula 110 may assume the second configuration 160, asdepicted in FIG. 1B. By external forces, such as when forced into ahousing of the medical device 108, the insertion cannula 110 may assumethe first configuration 136, e.g. a more flat configuration, which ispreferable for storing the insertion cannula 110 inside a housing, e.g.,inside a patch, as will be outlined in further detail below. Still otherembodiments, e.g., with the same radius of curvature in the storageposition and in the inserted position are feasible.

As depicted in FIG. 1C, the insertion cannula 110 may be configured tobe transformable from the second configuration 162 as depicted in FIG.1B, back to the first configuration 136. Further, the insertable element112 may be configured to retain a second configuration 170. Thus, theinsertable element 112, specifically the in vivo distal end 142, maykeep the arch form 168. Further, the middle part 152 may stay straight.

FIGS. 2A to 2B show exemplary embodiments of a medical device 108 indifferent perspective views. The medical device 108 comprises theinsertion cannula 110 and the insertable element 112. The insertioncannula 110 and the insertable element 112 correspond, at least in largepart, to the insertion cannula 110 and the insertable element 112 asillustrated in FIGS. 1A to 1C. Thus, reference may be made to thedescription of FIGS. 1A to 1C above.

As illustrated in FIG. 2A, the medical device 108 further comprises atleast one patch 172 configured to be mounted onto the skin of a user(not shown). The patch 172 comprises a patch base 174. The patch base174 may comprise a bottom side 176 and a front side 178. The insertioncannula 110 and the insertable element 112 may be located on the frontside 178 of the patch 172. The bottom side 176 may specifically be ormay comprise a flat surface 180. Thus, the patch 172 may be configuredto be attachable to the skin of the user via the bottom side 176. Forexample, the bottom side 176 may comprise an adhesive surface,specifically a plaster (not shown).

The patch 172 comprises an integrated insertion mechanism 182 configuredfor driving the insertion cannula 110 from the first configuration 136,which is taken when the insertion cannula 110 is in a storage positionwithin the patch 172 as shown in FIG. 2A, into the second configuration160, which is taken when the insertion cannula 110 is in an insertedposition as shown in FIG. 2B, extending into a body tissue. Theintegrated insertion mechanism 182, when driving the insertion cannula110 from the storage position into the inserted position, moves theinsertion cannula 110 on an insertion path, which is a curved insertionpath. As an example, a tip of the insertion cannula 110 may move along acurved insertion path. The integrated insertion mechanism 182 may belocated on the front side 178 of the patch 172.

The integrated insertion mechanism 182 may comprise at least one driveunit 184. The drive unit 184 may be configured to urge the insertioncannula 110 in the direction of insertion 158. The drive unit 184 maycomprise at least one flexible wire 186 configured for driving aninsertion of the insertable element 112. The flexible wire 186 may bereceived in a receptacle 187 of the patch 172. The flexible wire 186 maycomprise a first end 188 and a second end 190. The first end 188 may beconfigured to be attachable to the insertion cannula 110. Therefore, theflexible wire 186, specifically the first end 188, may comprise abearing area 192 for the insertion cannula 110. Further, the integratedinsertion mechanism 182 may comprise at least one pin 194. The pin 194may be attached to the second end 190 of the flexible wire 186. The pin194 may be engageable and/or driven by at least one element (not shown)connected or connectable to the patch base 174. Thereby, the integratedinsertion mechanism 182 may be configured to be driven by a connectingforce exerted via the pin 194 when connecting the element to the patchbase 174. Specifically, the drive unit 184 may be triggered or drivenvia a rotational mechanism. Therefore, the flexible wire 186 may have acurved shape.

The integrated insertion mechanism 182 may further comprise at least onereturn spring 196. The return spring 196 may be configured to support awithdrawing of the insertion cannula 110 from the body tissue afterinsertion. The return spring 196 may be located in a receptacle 198 ofthe patch base 174. The return spring 196 may comprise a first end 200.The first end 200 may be attachable to a side wall 202 of the receptacle198. Further, the return spring 196 may comprise a second end 204. Thesecond end 204 may be connectable to the insertion cannula 110,specifically via a protrusion 206 of the insertion cannula 110.

The insertion cannula 110 may be received in a further receptacle 208.The further receptacle 208 may be located parallel to the receptacle 198of the return spring 196. The insertion cannula 110 may be configured tobe movable within the further receptacle 208. The insertion cannula 110may be stored in the first configuration 136 inside the patch 172, asdescribed in FIG. 1A.

The medical device 108, specifically the patch 172, may comprise acircuit board 207 comprising electrical contacts 209. The electricalcontacts 209 may be configured to be electrically connectable to atleast one element interacting with the insertable element 112.

As illustrated in FIG. 2B, the insertion cannula 110, when beingtransformed into the second configuration 160, may at least partially belocated outside of the patch 172. Specifically, the insertion cannula110 may protrude from the patch 172. Therefore, the patch 172 maycomprise at least one passage opening 210. The insertion cannula 110 maybe movable from the patch 172 into the body tissue (not shown) throughthe passage opening 210 and vice versa. For further details on thesecond configuration 160 of the insertion cannula 110, reference may bemade to FIG. 1B.

The insertion cannula 110 may be configured to be movable along themajor axis 134 and within the further receptacle 208 via the integratedinsertion mechanism 182. Further, the insertion cannula 110 may beconfigured to be transformable into the second configuration 160 whenthe insertion cannula 110 passes the passage opening 210. The furtherreceptacle 208 may further be configured to receive the insertableelement 112, specifically when the insertable element 112 is in the flatshape 140.

FIG. 3 shows a further exemplary embodiment of a medical device 108 in aperspective view. The medical device 108 comprises the insertion cannula110, the insertable element 112 and the patch 172 (not shown). Theinsertion cannula 110, the insertable element 112 and the patch 172 maycorrespond, at least in large part, to the insertion cannula 110, theinsertable element 112 and the patch 172, as illustrated in FIGS. 1A to2B. Thus, reference may be made to FIGS. 1A to 2B above.

The patch 172 comprises the patch base 174 and at least one patch coverelement 223. The patch cover element 223 may be configured to cover theinsertion mechanism 182, at least partially. The medical device 108 mayfurther comprise at least one electronics unit 224 configured forinteracting with the insertable element 112. The electronics unit 224may comprise at least one electronics unit bayonet screw 226. The patch172 may comprise at least one patch bayonet contour 228. The patchbayonet contour 228 and the electronics unit bayonet screw 226, inconjunction, may form a bayonet connector 230 configured forestablishing a releasable mechanical connection between the electronicsunit 224 and the patch 172. In FIG. 3, the medical device 108 is shownin a mated state in which the releasable mechanical connection betweenthe electronics unit 224 and the patch 172 is established by the bayonetconnector 230. Thereby, the electronics unit 224 may be pressed onto thepatch 172 or vice versa, by means of the bayonet connector 230.

FIGS. 4A to 4D show an exemplary method for transcutaneously insertingan insertable element 112 into a body tissue. The medical device 108 asillustrated within FIGS. 4A to 4D may correspond, at least in largepart, to the medical devices 108 as illustrated in FIGS. 1A to 3. Thus,reference may be made to the description of FIGS. 1A to 3 above.

In a first step, as illustrated in FIG. 4A, the patch 172 is provided ina sterile packaging 232. The sterile packaging may be opened and theelectronics unit 224 may be attached to the patch 172, as illustrated inFIG. 4B. Specifically, the electronics unit 224 may be attached to thepatch 172 by placing the electronics unit bayonet screw 226 into thepatch bayonet contour 228 forming a bayonet connector 230, asillustrated in FIG. 3.

In a further step, as illustrated in FIG. 4C, the patch 172 with theelectronics unit 224 attached to the patch 172 may be placed onto theskin 234 of the user 236. Specifically, the patch 172 may be attached tothe skin 234 via the bottom side 176 of the patch 172. The bottom side176 may provide an adhesive surface 238.

Further, as illustrated in FIG. 4D, the insertable element 112 (notshown in FIG. 4D) may be inserted into the body tissue 240. The user 236may trigger the rotational mechanism as described within FIGS. 2A to 2Bvia a rotational movement of the electronics unit 224.

FIGS. 5A to 5G show a further exemplary embodiment of a medical device108 in perspective views (FIGS. 5A, 5C, 5E), in cross-sectional views(FIGS. 5B, 5D, 5F) and in an enlarged sectional view (FIG. 5G). Themedical device 108 corresponds partially to the medical device 108 asillustrated in FIGS. 2A to 2B. Thus, reference may be made to thedescription of FIGS. 2A to 2B above. Specifically, the medical device108 as illustrated in FIGS. 5A to 5G may provide an arrangement whereinthe insertable element 112 is situated further away from the insertioncannula 110 in comparison to the arrangement of the medical device 108as illustrated in FIGS. 2A to 2B.

The medical device 108 comprises the insertion cannula 110 and theinsertable element 112. Further, the medical device 108 comprises thepatch 172 configured to be mounted onto the skin of the user (notshown). The patch 172 comprises the patch base 174 and, optionally, apatch base cover element 243. Moreover, the patch 172 comprises theintegrated insertion mechanism 182. The medical device 108, specificallythe patch 172, may further comprise the circuit board 207 comprising theelectrical contacts 209.

The integrated insertion mechanism 182 may comprise the drive unit 184.The drive unit 184 may comprise the flexible wire 186. The second end190 of the flexible wire 186 may be received in a sleeve 242. At leastparts of the flexible wire 186 and the sleeve 242 may be received in thereceptacle 187 of the patch 172. The receptacle 187 may comprise acurved shape. The sleeve 242 may comprise a protrusion 244, which canalso be denoted as protrusion flexible wire. The protrusion 244 may beconfigured such that a movement of the flexible wire 186 may betriggered by at least one element (not shown) connectable to the patch172. Specifically, the movement of the flexible wire 186 may betriggered by a force exerted via the sleeve 242. The drive unit 184 maybe triggered via a rotational mechanism.

In FIGS. 5A and 5B, the insertion cannula 110 is in a storage positionwithin the patch 172 and may be transformed into the first configuration136. The insertion cannula 110 and the insertable element 112 may be atleast partially received in the further receptacle 208. Thereby, theinsertion cannula 110 may lie flat onto a surface 248 of the furtherreceptacle 208. The insertable element 112 may at least partially bereceived within the insertion cannula 110. Specifically, the in vivodistal end 142 of the insertable element 112 may be received within theinsertion cannula 110. Further, the insertable element 112 may bereceived in the further receptacle 208 in a two-layered fashion. The invivo distal end 142 may be received in the insertion cannula 110 whichmay lie flat onto the surface 248 of the further receptacle 208, whereinthe ex vivo proximal end 144 may be situated opposite to the in vivodistal end 142 and may extend parallel to the in vivo distal end 142 ina certain distance to the in vivo distal end 142. Thus, the middle part152 of the insertable element 112 may be in the curved shape 154. A bend250 of the insertable element 112 may extend in a directionperpendicular to a longitudinal axis 252 of the patch 172. Specifically,the bend 150 may be located in an end section 254 of the furtherreceptacle 208.

Further, the contact portion 150, specifically at least one zeroinsertion force (“ZIF”) connector 256, may be attached to the insertableelement 112 for providing an electrical connection to the insertableelement 112. The ZIF connector 256 may be located in a middle section258 of the further receptacle 208. Specifically, the ZIF connector 256may be fixedly attached to the patch 172, specifically to the patch basecover element 243.

The first end 188 of the flexible wire 186 may be received in a furthersleeve 246. The further 246 sleeve may comprise at least one firstfurther sleeve protrusion 260. The first further sleeve protrusion 260may lie on a patch base cover element receptacle 262 of the patch basecover element 243. The patch base cover element receptacle 262 mayextend parallel to the direction of extension 132 of the insertioncannula 110 and may have a straight, elongate shape. Thus, the furthersleeve 246 may be configured to be moveable along the direction of theextension 132 of the insertion cannula 110, the first further sleeveprotrusion 260 thereby moving within the patch base cover elementreceptacle 262. Further, the further sleeve 246 may have a secondfurther sleeve protrusion 264. The second further sleeve protrusion 264may be attached to one end 266 of the insertion cannula 110. Thus, theinsertion cannula 110 may be configured to be triggered by moving theflexible wire 186. In case the insertion cannula 110 is transformed intothe first configuration 136 as illustrated in FIGS. 5A and 5B, thefurther sleeve 246 may be located in the middle section 258 of thefurther receptacle 208.

Further, the integrated insertion mechanism 182 may comprise the returnspring 196. The return spring 196 may be configured to support awithdrawing of the insertion cannula 110 from the body tissue (notshown) after insertion. The return spring 196 may be located in thereceptacle 198. The first end 200 of the return spring 196 may beattached to the side wall 202 of the receptacle 198. The second end 204of the return spring may be fixedly attached to a cannula sleeve 268.When the insertion cannula 110 is transformed into the firstconfiguration 136, as illustrated in FIGS. 5A and 5B, the cannula sleeve268 may be attached to a further side wall 270 of the receptacle 198opposing the side wall 202 of the receptacle 198. Thereby, the returnspring 196 may be in an outstretched configuration 272. Moreover, thecannula sleeve 268 may comprise an arm 174. The arm 174 may extend alongthe direction of extension 132 of the insertion cannula 110 and may forma fixed connection between the cannula sleeve 268 and the insertioncannula 110. The further receptacle 208 may be located parallel to thereceptacle 198 of the return spring 196.

In FIGS. 5C, 5D, 5E and 5F, the insertion cannula is shown in aninserted position, taking the second configuration 160. As illustratedin FIGS. 5C and 5D, the insertion cannula 110, when being transformedinto the second configuration 160, may at least partially be locatedoutside of the patch 172. Thereby, the flexible wire 186 may be fully,or at least to a large extent, received in the receptacle 187. In thismanner, the cannula sleeve 268 may also be received in the receptacle187. Further, the cannula sleeve 268 may be located in a middle section276 of the receptacle 198 and the return spring 196 may be in atensioned configuration 278.

As the insertable element 112 may be at least partially located outsideof the patch 172, accordingly, the ex vivo proximal end 144 of theinsertable element 112 may be located in the middle section 258 of thefurther receptacle 208. Thus, the bend 250 of the insertable element 112may be located in the middle section 258 accordingly.

As illustrated in FIGS. 5E and 5F, the insertable element 112 may beconfigured to stay outside of the patch 172 when insertion cannula 110is withdrawn into the patch 172. The return spring 196 may be in theoutstretched configuration 272 and the cannula sleeve 268 may beattached to the further side wall 270 of the receptacle 198.

In FIG. 5G, an enlarged sectional view of the medical device 108 isshown. Specifically, parts of the receptacle 198 and of the furtherreceptacle 208 are illustrated. The further sleeve 246, specifically thefirst further sleeve protrusion 260, may be configured to be lifted fromthe patch base cover element receptacle 262 before the insertion cannula110 is withdrawn into the patch 172. Therefore, the patch base coverelement receptacle 262 may have a ramp 280. Specifically, the firstfurther sleeve protrusion 260 may be configured to be lifted beyond ahook 282 of the patch cover element 223. The second further sleeveprotrusion may comprise a second further sleeve protrusion receptacle284. The second further sleeve protrusion receptacle 284 may beconfigured to enclose the insertable element 112 at least partially toattach to the insertion cannula 110, specifically to the end 266 of theinsertion cannula 110. Thus, the ramp 280 may be configured todisconnect the second further sleeve protrusion receptacle 284 from theinsertion cannula 110 such that, afterwards, the insertion cannula 110may be withdrawn into the patch 172 such as illustrated in FIGS. 5E and5F.

FIGS. 6A to 6C show a further exemplary method for transcutaneouslyinserting an insertable element 112 into a body tissue. The method asillustrated within FIGS. 6A to 6C corresponds, at least in large part,to the method as illustrated within FIGS. 4A to 4D. Further, the medicaldevice 108 as illustrated within FIGS. 6A to 6C corresponds, at least inlarge part, to the medical device as illustrated in FIGS. 5A to 5G.Thus, reference can be made to the descriptions of FIGS. 4A to 4D and ofFIGS. 5A to 5G above.

Firstly, as illustrated in FIG. 6A, the patch 172 and the electronicsunit 224 may be provided. The electronics unit 224 may specifically beprovided as a separate component 286. Further, as illustrated in FIG.6B, the electronics unit 223 may be attached to the patch 172,specifically to the patch cover element 223, by placing the electronicsunit bayonet screw 226 into the patch bayonet contour 228, forming thebayonet connector 230. In a further step, as depicted in FIG. 6C, theinsertable element 112 may be inserted into the body tissue (not shown).Therefore, the rotational movement of the electronics unit 224 maytrigger the rotational mechanism.

FIGS. 7A and 7B show a further exemplary embodiment of a medical device108 in different perspective views. The medical device 108 as depictedin FIGS. 7A and 7B corresponds, at least in large part, to the medicaldevice 108 as illustrated in FIGS. 1A to 6C. Thus, reference may be madeto the descriptions of FIGS. 1A to 6C above.

The medical device 108 as depicted in FIG. 7A is shown in an initialstate 288, wherein the electronics unit 224 and the patch 172 areprovided as separate components 286. The patch 172 may comprise thepatch base 174. The patch base 174 may comprise the bottom side 176,which may specifically be, or may comprise, the flat surface 180. Thus,the patch 172 may be configured to be attachable to the skin, of theuser via the bottom side 176. For example, the bottom side 176 maycomprise an adhesive surface, specifically a plaster (not shown).

The medical device 108, specifically the integrated insertion mechanism182, may comprise a linear sliding mechanism 290. Specifically, theelectronics unit 224 may comprise two linear sliding receptacles 292.The linear sliding receptacles 292 may be located on longitudinal sides294 of the electronics unit 224, respectively. Further, the linearsliding receptacles 292 may have an elongate shape and may extend alonga longitudinal axis 296 of the electronics unit 224. Specifically, thelinear sliding receptacles 292 may have a straight shape. Complementaryto the linear sliding receptacles 292, the patch 172 may comprise atleast two linear sliding guide rails 298. The linear sliding guide rails298 may be located on longitudinal sides 300 of the patch 172. Thelinear sliding guide rails 298 may extend along a longitudinal axis 302of the patch 172. Further, the linear sliding guide rails 298 may have astraight shape. Specifically, the linear sliding guide rails 298 may beformed as a protrusion 304 of the patch 172.

Specifically, the linear sliding guide rails 298 of the patch 172 andthe linear sliding receptacle 292 may be shaped complementary to eachother. The linear sliding receptacle 292 may be configured to receivethe linear sliding guide rails 298. Thus, the linear sliding guide rails298 may have a shape and a size which correspond to the linear slidingreceptacles 292. For example, the linear sliding guide rails 298 mayhave a round shape and the linear sliding receptacle 292 may have around shape, too. Consequently, the electronics unit 224 may bemountable onto the patch 172 via the linear sliding receptacle 292, aswill further be described below in more detail.

Specifically, the patch 172 may be made of two parts 306. One of the twoparts 306 may be formed as a functional module 308 housing theintegrated insertion mechanism 182, the insertable element 112 and theinsertion cannula 110. The functional module 308 may be fixedly attachedto the other one of the parts 306.

Within this exemplary embodiment, the insertable element 112 mayspecifically be the sensor 146 having the contact portion 150 which mayspecifically be located at the ex vivo proximal end 144 of the sensor146. The ZIF connector 256 may be attached to the insertable element 112for providing an electrical connection between the electronics unit 224and the insertable element 112. Therefore, the ZIF connector 256 may beoperably connected to electrical contacts 310. Further, the integratedinsertion mechanism 182 may comprise the return spring 196. The returnspring 196 may be configured to support a withdrawing of the insertioncannula 110 from the body tissue after insertion, as will further bedescribed below in more detail. Specifically, the return spring 196 maybe located in the receptacle 198 of the patch 172. The return spring 176may comprise the first end 200, which may be attachable to the sidewalls 202 of the receptacle 198. Further, the return spring 196 maycomprise the second end 204. The second end 204 may be fixedly attachedto the cannula sleeve 268. A drive arm 312 which may be part of thedrive unit 184 may be configured to be moved linearly on the patch 172,specifically on the functional module 308. Therefore, the patch 172,specifically the functional module 308, may have a drive arm receptacle314 which is configured such that the drive arm 312 is linearly movableon the patch 172. One end 316 of the drive arm 312, opposing an end 318of the drive arm 312, which is fixedly attached to the cannula sleeve268, may comprise a fixation element 320. The insertable element 112 maybe fixedly attached to the drive arm 312 via the fixation element 320.

FIGS. 8A and 8B show a further exemplary embodiment of a medical device108 in different perspective views. The medical device 108 as shown inFIGS. 8A and 8B corresponds, at least in large part, to the medicaldevice 108 as illustrated in FIGS. 7A and 7B. Thus, reference may bemade to the description of FIGS. 7A and 7B above.

The medical device 108 as shown in FIG. 8A is shown in a second state322. In the second state 322, the electronics unit 224 and the patch 174are in an assembled state 324. The linear sliding receptacles 292 andthe linear sliding guide rails 298, in conjunction, form a linearsliding connector 325 configured for establishing a releasablemechanical connection between the electronics unit 224 and the patch172. The linear sliding guide rail 298 of the patch 172 is received inthe linear sliding receptacle 292 of the electronics unit 224 (notshown).

In FIG. 8B, the functional module 308 is shown. When the electronicsunit 224 is mounted onto the patch 172 via the linear sliding mechanism290, the insertion cannula 110 may be transformed into the secondconfiguration 160 and may, at least partially, be located outside of thepatch 172 in the inserted position. By applying the linear slidingmechanism 172, the drive arm 312 may be configured to be moved along thedrive arm receptacle 314 of the patch 172. Specifically, the electronicsunit 124 may move a drive arm protrusion 324, which may exemplarily belocated at the end 318 of the drive arm 312. The insertable element 112may be configured to be moved along with the insertion cannula 110 asthe insertable element 112 is fixedly attached to the drive arm 312 viathe fixation element 320. Further, the return spring 196 may beconfigured to be compressed when the linear sliding mechanism 290 isapplied.

FIGS. 9A and 9B show a further exemplary embodiment of the medicaldevice 108 in different perspective views. The medical device 108 asillustrated in FIGS. 9A and 9B corresponds, at least in large part, tothe medical device 108 as illustrated in FIGS. 7A to 8B. Thus, referencemay be made to the description of FIGS. 7A to 8B above.

In FIGS. 9A and 9B, the medical device 108 is shown in a third state 326wherein the insertion cannula 110 may be withdrawn into the patch 172.The insertable element 112 may be configured to stay outside of thepatch 172. The return spring 196 may be in the outstretchedconfiguration 172 as illustrated in FIG. 9B and the cannula sleeve 268may be configured to move from the end 318 of the drive arm 312 to theend 316 of the drive arm 312. The cannula sleeve 268 may have a cannulasleeve protrusion 328 which may be movably received in a cannula sleeveprotrusion receptacle 330 of the drive arm 312. The cannula sleeveprotrusion receptacle 330 may extend along the drive arm 312.

FIGS. 10A to 10B show a further exemplary embodiment of a medical device108 in different perspective views. The medical device 108 asillustrated in FIGS. 10A and 10B corresponds, at least in large part, tothe medical device 108 as illustrated in FIGS. 7A to 9B. Thus, referencemay be made to the description of FIGS. 7A to 9B above.

In FIG. 10A, the electronics unit 124 and the patch 172 are shown in aninitial state 288. The electronics unit 124 and the patch 172 may be ina disassembled state 289. The medical device 108, specifically theintegrated insertion mechanism 182, may have the linear slidingmechanism 290. The electronics unit 124 may have the linear slidingreceptacles 292 and the patch 172 may have the linear sliding guiderails 298.

Further, the patch 172 may comprise the two parts 306. One of the twoparts 306 may correspond to the functional module 308 which isillustrated in FIG. 10B. The functional module 308 may have theinsertable element 112 which is at least partially received in theinsertion cannula 110. The integrated insertion mechanism 182 may havethe return spring 196. The return spring 196 may be received in thereceptacle 198. Further, the insertion cannula 110 may also be receivedin the receptacle 198. Specifically, the insertion cannula 110 may bereceived within an interior 332 of the return spring 196. The first end200 of the return spring 196 may be attachable to the sidewall 202 ofthe receptacle 198. Further, the return spring 196 may comprise thesecond end 204. The second end 204 may be attached to the cannula sleeve268. The cannula sleeve 268 may have a cannula sleeve extension 334which extends from the cannula sleeve 268 into the return spring 196.The cannula sleeve extension 334 may have a cannula sleeve extensionopening 336 which fully penetrates the cannula sleeve 268, specificallythe cannula sleeve extension 334, along a direction of extension 338.The middle part 152 of the insertable element 112 may be inserted orreceived in the cannula sleeve extension opening 336. Thus, the in vivodistal end 142 (not shown) may be received in the insertion cannula 110,and the ex vivo proximal end 144 may be received in a receptacle 340 ofthe patch 172 adjacent to the receptacle 198.

In FIGS. 11A and 11B, a further exemplary embodiment of the medicaldevice 108 is shown. The medical device 108 corresponds, at least inlarge part, to the medical device 108 as shown in FIGS. 10A to 10B.Thus, reference can be made to the description of FIGS. 10A and 10Babove.

The medical device 108 as shown in FIG. 11A is shown in a second state346. In the second state 346, the electronics unit 224 and the patch 174are in an assembled state 348. The linear sliding guide rail 298 of thepatch 172 is received in the linear sliding receptacle 292 of theelectronics unit 224.

In FIG. 11B, the functional module 308 is shown. When the electronicsunit 224 is mounted onto the patch 172 via the linear sliding mechanism290, the insertion cannula 110 is transferred from the storage positioninside the patch 172 into the inserted position, thereby beingtransferred into the second configuration 160 and may, at leastpartially, be located outside of the patch 172. When being transferredfrom the storage position inside the patch 172 into the insertedposition, the insertion cannula 110, e.g., a tip of the insertioncannula 110, as in the other embodiments, moves along a curved insertionpath. By applying the linear sliding mechanism 290, the cannula sleeve268 may be configured to be moved along the receptacle 198 of the patch172. Further, the return spring 196 may be configured to be compressedwhen the linear sliding mechanism 290 is applied.

In FIGS. 12A and 12B, a further exemplary embodiment of the medicaldevice 108 is shown. The medical device 108 corresponds, at least inlarge part, to the medical device 108 as shown in FIGS. 10A to 11B.Thus, reference can be made to the description of FIGS. 10A and 11Babove.

In FIGS. 12A and 12B, medical device 108 is shown in a third state 350.Thereby, the insertion cannula 110 may be withdrawn into the patch 172.The insertable element 112 may be configured to stay outside of thepatch 172. The return spring 196 may be in the outstretchedconfiguration 172 as illustrated in FIG. 12B and the cannula sleeve 268may be configured to move from the sidewall 202 of the receptacle 198 tothe further sidewall 270 of the receptacle 198.

In FIGS. 13A to 13E, a further embodiment of a medical device 108 isshown, which, in large part, is similar to the embodiments shown inFIGS. 7A to 12B. FIG. 13A shows a perspective view of the medical devicein a closed state; FIG. 13B shows a perspective view with an electronicsunit removed, in a standby position; FIG. 13C shows the setup of FIG.13B in a semi-actuated position; and FIG. 13D shows the setup of FIG.13B in an actuated position. FIG. 13E shows a cross-sectional view in afully actuated position. FIG. 14 shows a further exemplary embodiment ofan insertion cannula to be used in the setup of FIGS. 13A to 13E. FIGS.13A to 13E and 14 will be explained in conjunction below.

The medical device 108, as shown in FIG. 13A, as in the exemplaryembodiments of FIGS. 7A and 12B, again, comprises a patch 172 with apatch base 174 for attachment to the skin of the user. Further, themedical device 108 may comprise an electronics unit 224, as depicted inFIG. 13A, or, additionally or alternatively, another functional unit,such as a pump unit, depending on the functionality of the medicaldevice 108. The electronics unit 224 and/or the functional unit may beconnected to the patch base 174, by using guide rails and/or other typesof connection mechanisms.

Further, as in the preceding exemplary embodiments, the medical device108, again, comprises an insertion cannula 110, with an insertableelement 112 disposed therein. An exemplary embodiment of the insertioncannula 110 is shown in FIG. 14. The insertion cannula 110, as anexample, may be a slotted insertion cannula 114, having a rectangularcross section and having a slot 128 disposed at a smaller side of theinsertion cannula 110. The insertion cannula 110 comprises a wall 124which, as an example, may be made of flexible stainless steel. Inabsence of external forces, e.g., in the inserted position shown inFIGS. 13D and 13E, the insertion cannula 110, which is a pre-bendedinsertion cannula 110, may assume a second configuration 160, asdepicted in FIG. 14, in which the insertion cannula 110 is bent. Whenretracted into the patch 172, i.e. into the storage position, theinsertion cannula 110, as shown, e.g., in FIG. 13B, may assume a firstconfiguration 136, in which the insertion cannula 110 may bended to alesser extent or is stored even in an essentially flat configuration,into which the insertion cannula 110 may be forced by the patch 172.Alternatively, in the storage position, the insertion cannula 110 mayalso have the same radius of curvature as in the extended position, suchthat the insertion cannula, in the first and second configurations 136,160, may also have the same configuration of bending.

The medical device 108, again, comprises an integrated insertionmechanism 182, which, in this exemplary embodiment, is designed as alinear sliding mechanism 290. The linear sliding mechanism 290, as inthe preceding embodiments of FIGS. 7A to 12B, may fully or partially beactuated by at least one element connected or connectable to the patchbase 174. Thus, the integrated insertion mechanism 182 may be configuredfor being driven by a connecting force exerted when connecting the atleast one element to the patch base. In principle, the electronics unit224 and/or another type of functional unit connected or connectable tothe patch base 174 may be used for actuating the integrated insertionmechanism 182. In this embodiment shown in FIGS. 13A to 13E, however, aseparate slider 352 is used as an element connected or connectable tothe patch base 174, for driving the insertion mechanism 182. Thisadditional slider 352, as an example, may have the shape of a “U” and/ormay form a bracket 354. The slider 352 may be configured for slidingalong an outer side of the patch base 174 by using a linear slidingguide rail 298 of the patch base 174 and a linear sliding receptacle 292of the slider 352 which, in conjunction, may form a sliding connector325, which may be releasable. The slider, by the linear slidingconnector 325, may be brought from a standby position 356, as shown inFIGS. 13A and 13B, over one or more semi-actuated positions 358, asshown e.g. in FIG. 13C, into an actuated position 360, as shown in FIG.13D. In the standby position, as shown in FIG. 13B, the insertioncannula 110 may be in the storage position, assuming the firstconfiguration 136, with the insertable element 112 disposed therein. Inthe semi-actuated position 358, shown in FIG. 13C, the insertion cannula110 may be transferred into the body tissue, thereby continuously beingtransferred from the storage position into the inserted position andbeing transformed from the first configuration 136 into the secondconfiguration 160. Again, when being transferred from the storageposition into the inserted position, the insertion cannula 110, e.g., atip of the insertion cannula 110, moves along a curved insertion path.The insertion cannula 110 may be pushed into the body tissue by thedriving force exerted by the slider 352. Simultaneously, one or, as inthis exemplary embodiment, two return springs 196 may be compressed, asshown in FIG. 13C. Once fully extended into the body tissue, as shown bythe transition between FIGS. 13C and 13D, the insertion cannula 110 ismechanically decoupled from the slider 352 and is retracted into thepatch base 174 by the return springs 196. The insertable element 112remains inside the body tissue, held e.g. by a protrusion 156, asdiscussed above in the context of FIGS. 1A to 1C.

In the standby position, the slider 352, as an example, may be securedby at least one removable securing element 362, as shown e.g. in FIG.13A. The removable securing element 362, as an example, may simply beforced into the U-shape, thereby preventing the slider 352 from beingpushed into the actuated position 360. The securing element 362 mayprovide multiple functions. Thus, besides the securing effect, thesecuring element 362 may also be used for desiccation purposes and,thus, may fully or partially be made of a desiccant 364.

As shown in the cross-sectional view of FIG. 13E, the electronics unit224 may be connected to the patch 172 and/or to the patch base 174 by anelectronics unit plug 366. Depending on the type of connection betweenthe electronics unit 224 and the patch base 174, other types ofelectrical connectors may also be used. Further, depending on the typeof insertable element 112, the insertable element 112 may also beconnected to one or more of the patch 172, the patch base 174, theelectronics unit 224 and/or another type of functional element connectedto the patch base 174, such as a pump unit. In the exemplary embodimentshown in FIG. 13E, as an example, the insertable element 112 may fullyor partially be embodied as a sensor 146, specifically as an analytesensor 148, which may be connected to the patch base 174 via at leastone sensor plug 368, as discussed previously, e.g., in the context ofFIG. 7B. Other connections are feasible, e.g., in the case of theinsertable element 112 being an infusion cannula, a fluid connection.

As shown in the embodiment of FIGS. 13A to 13E, as well as in thepreceding embodiments, at least one element connected or connectable tothe patch base 174 may be used for driving the insertion cannula 110.The element connected or connectable to the patch base 174 may, asoutlined above, be or may comprise a bracket or an electronics unit oranother type of element. As shown therein, the term “connectable to thepatch base” generally may imply the option that the element is broughtfrom a first position into a second position, relative to the patch base174. Thus, as shown in FIG. 13A and in FIG. 13B, the slider 352, in thestandby position 356, protrudes from the patch 172 and from an overallhousing 370 of the medical device 108. This state, which may also bereferred to as a disconnected state, is transferred into the state shownin FIG. 13D and in FIG. 13E, in which the slider 352 is in the actuatedposition 360, thereby being connected to the patch base 174. In thisstate, the slider 352 is flush with a housing 370 of the medical device108 and does not protrude from the housing 370 any longer and forms partof this housing 370.

In FIGS. 15A to 15D, a further embodiment of a medical device 108 isshown, which is largely similar to the embodiment shown above in FIGS.13A to 13E. Thus, for the most part, reference may be made to thedescription of these Figures above. FIG. 15A shows a perspective view ofthe medical device 108; FIG. 15B shows the medical device 108 in astandby position, with the insertion cannula 110 in a storage positionwithin the patch 172; FIG. 15C shows the setup in a semi-actuatedposition, with the insertion cannula 110 being in a fully extendedposition; and FIG. 15D shows the setup with the insertion cannula 110being retracted into the patch 172 when the integrated insertionmechanism 182 is further moved towards the fully actuated position (notshown).

The embodiment in FIGS. 15A to 15D differs from the embodiment above inFIGS. 13A to 13E by minor details. For example, as can be seen whencomparing FIGS. 15B and 15C, this embodiment shows that the insertioncannula 110, in the storage position and first configuration, and in theinserted position and a second configuration, may also basically havethe same radius of curvature. Again, as in the other embodiments, theinsertion cannula 110, e.g., a tip of the insertion cannula 110, moveson a curved insertion path during insertion.

While exemplary embodiments have been disclosed hereinabove, the presentinvention is not limited to the disclosed embodiments. Instead, thisapplication is intended to cover any variations, uses, or adaptations ofthis disclosure using its general principles. Further, this applicationis intended to cover such departures from the present disclosure as comewithin known or customary practice in the art to which this inventionpertains and which fall within the limits of the appended claims.

LIST OF REFERENCE NUMBERS

-   108 medical device-   110 insertion cannula-   112 insertable element-   114 slotted cannula-   116 end-   118 slot-   120 longitudinal axis-   122 lumen-   124 wall-   128 slot-   130 axial direction-   132 direction of extension-   134 major axis-   136 first configuration-   138 essentially straight shape-   140 essentially flat shape-   142 in vivo distal end-   144 ex vivo proximal end-   146 sensor-   148 analyte sensor-   150 contact portion-   152 middle part-   154 curved shape-   156 protrusion-   158 direction of insertion-   160 second configuration-   162 pre-programmed configuration-   164 curvature-   166 arch form-   168 arch form-   170 previous configuration-   172 patch-   174 patch base-   176 bottom side-   178 front side-   180 flat surface-   182 integrated insertion mechanism-   184 drive unit-   186 flexible wire-   187 receptacle-   188 first end-   190 second end-   192 bearing area-   194 pin-   196 return spring-   198 receptacle-   200 first end-   202 sidewall-   204 second end-   206 protrusion-   207 circuit board-   208 further receptacle-   209 electrical contact-   210 passage opening-   223 patch cover element-   224 electronics unit-   226 electronics unit bayonet screw-   228 patch bayonet contour-   230 bayonet connector-   232 sterile packaging-   234 skin-   236 user-   238 adhesive surface-   240 body tissue-   242 sleeve-   243 patch base cover element-   244 protrusion-   246 further sleeve-   248 surface-   250 bend-   252 longitudinal axis-   254 end section-   256 ZIF connector-   258 middle section-   260 first further sleeve protrusion-   262 patch base cover element receptacle-   264 second further sleeve protrusion-   266 end-   268 cannula sleeve-   270 further side wall-   272 outstretched configuration-   274 arm-   276 middle section-   278 tensioned configuration-   280 ramp-   282 hook-   284 second further sleeve protrusion receptacle-   286 separate component-   288 initial state-   289 disassembled state-   290 linear sliding mechanism-   292 linear sliding receptacle-   294 longitudinal side-   296 longitudinal axis-   298 linear sliding guide rail-   300 longitudinal side-   302 longitudinal axis-   304 protrusion-   306 part-   308 functional module-   310 electrical contact-   312 drive arm-   314 drive arm receptacle-   316 end-   318 end-   320 fixation element-   322 second state-   324 drive arm protrusion-   326 third state-   328 cannula sleeve protrusion-   330 cannula sleeve protrusion receptacle-   332 interior-   334 cannula sleeve extension-   336 cannula sleeve extension opening-   338 direction of extension-   340 receptacle-   342 ex vivo proximal end-   344 second end-   346 second state-   348 assembled state-   350 third state-   352 slider-   354 bracket-   356 standby position-   358 semi-actuated position-   360 actuated position-   362 securing element-   364 desiccant-   366 electronics unit plug-   368 sensor plug-   370 housing

What is claimed is:
 1. A medical device for transcutaneously insertingan insertable element into a body tissue, wherein the medical devicecomprises: an insertable element, wherein the insertable elementincludes an in vivo distal end for subcutaneous insertion and at leastone ex vivo proximal end; an insertion cannula for subcutaneouslyinserting the insertable element, the insertion cannula having a lumenwhich fully or partially is enclosed by a wall of the insertion cannula,wherein the insertable element is received in the lumen, wherein theinsertion cannula is a pre-bended insertion cannula; wherein the medicaldevice further comprises at least one patch configured to be mountedonto the skin of a user, wherein the patch comprises a patch base and anintegrated insertion mechanism for driving the insertion cannula from astorage position within the patch into an inserted position within thebody tissue; and wherein the insertion cannula has a tip and the tip ofthe insertion cannula follows an insertion path, during movement of theinsertion cannula from the storage position to the inserted position,that is at least partially non-straight.
 2. The medical device accordingto claim 1, wherein the insertion cannula is at least partially made ofa material selected from the group consisting of: steel, stainlesssteel, and a plastic material.
 3. The medical device according to claim1, wherein the insertion cannula is pre-bended in such that theinsertion cannula at least partially has the shape of a segment of acircle.
 4. The medical device according to claim 3, wherein theinsertion path is at least partially shaped as a segment of a circle. 5.The medical device according to claim 1, wherein the medical device isconfigured such that the insertion cannula is withdrawn into the medicaldevice after insertion of the insertable element.
 6. The medical deviceaccording to claim 1, wherein the integrated insertion mechanismcomprises a drive unit configured to urge the insertion cannula in adirection of insertion.
 7. The medical device according to claim 1,wherein the integrated insertion mechanism is a linear slidingmechanism.
 8. The medical device according to claim 1, wherein themedical device further comprises at least one element connected orconnectable to the patch base, wherein the integrated insertionmechanism is configured to be driven by a connecting force exerted whenconnecting the element to the patch base or when moving the elementrelative to the patch base.
 9. The medical device according to claim 8,wherein the at least one element connected or connectable to the patchbase comprises a linear sliding receptacle and the patch comprises alinear sliding guide rail or vice versa, wherein the linear slidingreceptacle and the linear sliding guide rail in conjunction form alinear sliding connector configured for moving the element relative tothe patch base or for establishing a releasable mechanical connectionbetween the at least one element connectable to the patch base and thepatch.
 10. The medical device according to claim 8, wherein the at leastone element connected or connectable to the patch base comprises anelement selected from the group consisting of: an electronics unitconfigured for interacting with the insertable element; a slider; and abracket.
 11. The medical device according to claim 8, wherein the atleast one element connected or connectable to the patch base isconfigured to be brought from a standby position into an actuatedposition, wherein the medical device is configured to insert theinsertion cannula into the body tissue when the at least one elementconnected or connectable to the patch base is brought into the actuatedposition.
 12. The medical device according to claim 11, wherein themedical device is further configured for retracting the insertioncannula once the actuated position has been reached.
 13. The medicaldevice according to claim 11, wherein the medical device furthercomprises at least one removable securing element, wherein the securingelement is configured for securing the at least one element connected orconnectable to the patch base in the standby position.
 14. The medicaldevice according to claim 11, wherein the at least one element connectedor connectable to the patch base, when in the actuated position, isflush with a housing of the medical device.
 15. An analyte measurementdevice for detecting at least one analyte in a body fluid, the analytemeasurement device comprising at least one medical device according toclaim 1, wherein the insertable element comprises an analyte sensor fordetecting the at least one analyte in the body fluid, the analytemeasurement device further having an evaluation device interacting withthe analyte sensor.
 16. A medication device for delivering at least onemedication to a user, the medication device comprising at least onemedical device according to claim 1, wherein the insertable elementcomprises at least one of an infusion cannula or a dosing tube, whereinthe medication device further comprises a medication pump fluidlycoupled to the insertable element.
 17. A method for transcutaneouslyinserting an insertable element into a body tissue, wherein the methodcomprises: a) providing at least one medical device according to claim1, the medical device further including an electronics unit; b) placingthe patch base onto the skin; and c) inserting the insertable elementinto the body tissue.
 18. The medical device according to claim 1,wherein the insertion cannula has a first configuration when in thestorage position and a second configuration when in the insertedposition and wherein the insertion cannula is bent to a lesser extent inthe first configuration than in the second configuration.
 19. Themedical device according to claim 18 wherein the insertion cannula is inthe first configuration when retracted into the patch and assumes thesecond configuration when extended outside the patch.